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• W3204993131 abstract "Free AccessScientific InvestigationsA randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance Alice Y. Tu, MA, Megan R. Crawford, PhD, Spencer C. Dawson, PhD, Louis F. Fogg, PhD, Arlener D. Turner, PhD, James K. Wyatt, PhD, Maria I. Crisostomo, MD, Bantu S. Chhangani, MD, Clete A. Kushida, PhD, Jack D. Edinger, PhD, Sabra M. Abbott, MD, PhD, Roneil G. Malkani, MD, Hrayr P. Attarian, MD, Phyllis C. Zee, MD, PhD, Jason C. Ong, PhD Alice Y. Tu, MA Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois Search for more papers by this author , Megan R. Crawford, PhD School of Psychological Sciences and Health, University of Strathclyde, Glasgow, United Kingdom Search for more papers by this author , Spencer C. Dawson, PhD Department of Psychological and Brain Sciences, Indiana University, Bloomington, Indiana Search for more papers by this author , Louis F. Fogg, PhD College of Nursing, Rush University Medical Center, Chicago, Illinois Search for more papers by this author , Arlener D. Turner, PhD Center for Translational Sleep and Circadian Sciences, Department of Psychiatry and Behavioral Sciences, University of Miami, Miami, Florida Search for more papers by this author , James K. Wyatt, PhD Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois Search for more papers by this author , Maria I. Crisostomo, MD Search for more papers by this author , Bantu S. Chhangani, MD Department of Medicine, Rush University Medical Center, Chicago, Illinois Search for more papers by this author , Clete A. Kushida, PhD Division of Sleep Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California Search for more papers by this author , Jack D. Edinger, PhD Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, Colorado Search for more papers by this author , Sabra M. Abbott, MD, PhD Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Search for more papers by this author , Roneil G. Malkani, MD Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Neurology Service, Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois Search for more papers by this author , Hrayr P. Attarian, MD Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Search for more papers by this author , Phyllis C. Zee, MD, PhD Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Search for more papers by this author , Jason C. Ong, PhD Address correspondence to: Jason C. Ong, PhD, Department of Neurology, Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, 710 North Lake Shore Drive, Room 1004, Chicago, IL 60611; Email: E-mail Address: [email protected] Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Nox Health, Suwanee, Georgia Search for more papers by this author Published Online:March 1, 2022https://doi.org/10.5664/jcsm.9696Cited by:1SectionsAbstractEpubPDFSupplemental Material ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutABSTRACTStudy Objectives:This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning.Methods:A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures.Results:A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all P < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring.Conclusions:Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes.Clinical Trial Registration:Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303.Citation:Tu AY, Crawford MR, Dawson SC, et al. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022;18(3):789–800.BRIEF SUMMARYCurrent Knowledge/Study Rationale: Patients with comorbid insomnia and sleep apnea often experience significant daytime dysfunction and greater sleep disturbance compared to each condition alone. Recent studies have focused on positive airway pressure (PAP) adherence and insomnia remission, but the effect of concomitant treatment using PAP and cognitive behavioral therapy for insomnia on nocturnal sleep parameters and daytime functioning remains unclear. This study addressed this research gap by examining secondary analysis on a randomized controlled trial using PAP and cognitive-behavioral therapy for insomnia in comorbid insomnia and sleep apnea.Study Impact: The findings revealed more rapid effects on self-reported sleep and daytime functioning when receiving cognitive behavioral therapy for insomnia prior to or concurrent with PAP, compared to PAP alone. Concomitant treatment using cognitive behavioral therapy for insomnia and PAP appears to be a favorable approach to accelerate treatment outcomes in sleep parameters and certain domains of daytime functioning.INTRODUCTIONObstructive sleep apnea (OSA) is a common sleep-related breathing disorder that affects approximately 10–30% of the population.1,2 OSA often coexists with insomnia disorder, which is characterized by persistent difficulty falling asleep, difficulty maintaining sleep, or early morning awakening. Patients with comorbid insomnia and sleep apnea (COMISA) often have mixed symptoms from both disorders, such as fragmented sleep, trouble falling asleep, and poor daytime functioning.3–5 Several reviews have concluded that the prevalence rate of COMISA is between 30–60%, with the variability likely due to different criteria used for insomnia and sleep-disordered breathing.3,6,7Clinical management for patients with COMISA has been challenging, as they present a broad range of symptoms that are difficult to manage using singular treatment approaches for OSA or insomnia.8 A concomitant approach using positive airway pressure (PAP) therapy and cognitive behavioral therapy for insomnia (CBT-I) has emerged as a potential strategy since both PAP and CBT-I are considered first-line treatments for OSA and insomnia, respectively.9,10 Recent clinical trials have found that this concomitant approach can be efficacious for reducing insomnia symptoms with mixed findings on improving PAP adherence.11–14Beyond these clinical endpoints, there is a need to understand the impact of treatments on other key aspects of COMISA, including nocturnal sleep parameters and daytime functioning. These factors are likely to drive patient complaints and subsequent adherence to treatments. Previous studies have found that people with COMISA have longer sleep onset latency (SOL) and more difficulty maintaining sleep compared to people with OSA only,15–18 as well as longer wake after sleep onset (WASO) compared to people with insomnia alone.15 In addition, COMISA is associated with significant daytime sleepiness,19 dysfunctional sleep-related beliefs, depression, anxiety,17,20 and medical consequences (eg, cardiovascular diseases).21 Gooneratne et al22 also reported significantly lower global scores on the Functional Outcomes of Sleepiness Questionnaire (FOSQ) in individuals with COMISA compared to healthy controls. In a recent study,23 Alessi et al found that an integrated behavioral treatment using CBT-I and PAP adherence techniques improved FOSQ-10 scores and daytime sleepiness at 3-month follow-up in people with COMISA. Additionally, they observed greater improvements in sleep diary-measured SOL as well as sleep diary- and actigraphy-measured sleep efficiency (SE) from baseline to 3-month follow-up in participants who received CBT-I and PAP adherence program compared to the control group (general sleep education). In a series of studies, Sweetman et al also found that CBT-I improved both polysomnography- and sleep diary-measured sleep outcomes, including SOL, WASO, and SE in people with COMISA.12,14 Furthermore, they found that sleepiness levels immediately returned to pretreatment level after a 15% increase in the first week of receiving CBT-I, indicating that increases in sleepiness are transient during treatment. In addition, they reported a reduction in dysfunctional sleep-related beliefs in those who received the combined treatment of CBT-I and PAP compared to PAP alone. However, no other between-group difference was found in their studies in the improvements of daytime functioning, including daytime sleepiness and fatigue.12,14The purpose of this study was to examine clinical measures of sleep and daytime performance as part of a planned series of analyses from a randomized controlled trial on PAP and CBT-I in people with COMISA. This report builds upon the main outcomes previously reported (PAP adherence, self-reported sleep quality (SQ), and insomnia severity index)13 to investigate other key clinical domains relevant to COMISA. The primary aim of this study was to examine the effects of the treatment combinations using CBT-I and PAP and the relative benefits of each treatment on sleep parameters and daytime functioning. We hypothesized that the combination of CBT-I and PAP would improve sleep outcomes (reductions in SOL and WASO and increases in total sleep time [TST] and SE) and daytime functioning compared to PAP treatment alone. In addition, a novel aspect of this study was the use of a partial factorial design. Therefore, the secondary aim was to conduct planned comparisons to examine the changes during each treatment condition (CBT-I and PAP) in these outcome measures.METHODSStudy design and procedureThis study was a three-arm randomized controlled trial using a partial factorial design.24 All three treatment arms consisted of two phases: Arm A, CBT-I in Phase 1 followed by PAP in Phase 2; Arm B, self-monitoring in Phase 1 followed by CBT-I and PAP initiated concurrently in Phase 2; and Arm C, self-monitoring in Phase 1 followed by PAP only in Phase 2 (see Figure S1 in the supplemental material for study procedure flow chart). Eligible participants were randomized to one of three study arms based on a randomization scheme, which was created by random size blocks of 3 or 6 and stratified by OSA severity (mild: apnea-hypopnea index [AHI] ≥ 5 events/h and < 15 events/h; moderate-to-severe: AHI ≥ 15 events/h). Outcome measures of sleep, daytime functioning, and cognitive-emotional measures were collected during the in-person screening evaluation at baseline (Assessment 1). The same measures were also assessed at the end of Phase 1/the time PAP titration was conducted (Assessment 2), after Phase 2/30 days after PAP initiation (Assessment 3), and 90 days after PAP initiation (Assessment 4).ParticipantsThe study was conducted at two sites (Rush University Medical Center and Northwestern University Feinberg School of Medicine). Participants were recruited from the community and through referrals from health care providers at each site from 2013 to 2018. A three-step screening process was administered to potential participants, consisting of (1) a preliminary eligibility screening through telephone; (2) an in-person evaluation using the Structured Diagnostic Interview for DSM-IV,25 the Duke Structured Interview Schedule for Sleep Disorders,26 and physical and medical history examination; and (3) an overnight in-laboratory polysomnography to determine OSA criteria and other exclusion criteria. The study protocol was approved by the Institutional Review Board at each site (Rush University #11090801-IRB01; Northwestern University #STU00203478). Written informed consents were obtained from all participants at the beginning of the in-person screening interview. See Figure 1 for the CONSORT flowchart.Figure 1: CONSORT flowchart.CBT-I = cognitive behavioral therapy for insomnia, CONSORT = Consolidated Standards of Reporting Trials, PAP = positive airway pressure.Download FigureInclusion criteria were (1) age 18 years and over; (2) International Classification of Sleep Disorders, second edition criteria for OSA (AHI ≥ 5 events/h on a full-night in-lab baseline polysomnography and the presence of at least one of the following clinical symptoms: daytime sleepiness or fatigue, unrefreshing sleep, gasping, choking, or holding breath at night, witnessed apneas or loud snoring); and (3) International Classification of Sleep Disorders, second edition criteria for insomnia disorder, including a presence of difficulty initiating sleep, maintaining sleep, or waking too early for at least 3 months, coupled with at least one area of significant daytime impairment or distress. In addition, participants had to show an SOL or WASO > 30 minutes for at least 3 nights per week through a 1-week sleep diary.Exclusion criteria included (1) medical and psychiatric conditions that were unstable or judged to interfere with the study protocol or required immediate treatment (eg, substance abuse, cognitive disorder, suicidal ideation); (2) other comorbid sleep disorders that required treatment outside of the study protocol; (3) severe OSA that required immediate treatment (AHI > 100 events/h or arterial oxygen saturation < 80% for more than 10% of TST); (4) active use of sedative-hypnotics; (5) excessive daytime sleepiness (Epworth Sleepiness Scale [ESS] > 16, or a score of 3 on the ESS question about risk of dozing “in a car, while stopped for a few minutes in traffic” or reporting excessive sleepiness while operating a motor vehicle); (6) use of CBT-I or PAP within 6 months prior to screening; and (7) unstable living environment for PAP setup and home use.InterventionsPAP therapyAll participants received PAP treatment during Phase 2 following the standard of care procedures recommended by the American Academy of Sleep Medicine. Participants were given a standard PAP machine (PAP/Auto PAP Models 460 and 560; Phillips Respironics, Murrysville, PA) in an in-home setting instructed by a trained health care provider. The PAP titration sleep study was conducted at the beginning of Phase 2 (Assessment 2) by a board-certified sleep physician to determine the prescribed pressure or pressure range. Participants were contacted by the research staff 1 week after setup to verify the initiation of PAP use. No behavioral interventions for insomnia or PAP adherence were provided to the participants during this process. Participants were given a 90-day period to use the PAP machine and adherence data were collected at 30 and 90 days.CBT-IThis study used a 4-session, in-person CBT-I protocol. The components of CBT-I included sleep restriction, stimulus control, relaxation, sleep hygiene, and cognitive strategies (eg, cognitive restructuring) (see Table S1 in the supplemental material for protocol outline). CBT-I was delivered to the participants in Arm A during Phase 1 and Arm B during Phase 2 by a trained clinician (postdoctoral fellow or staff sleep psychologist) under the supervision of a behavioral sleep medicine certified clinical psychologist (J.C.O.). No instructions related to OSA management or treatment were provided to the participants during the CBT-I.Self-monitoring programDuring Phase 1, participants in Arm B and Arm C were instructed to complete sleep diaries for 4 weeks and were contacted by the research staff to review the diaries. This self-monitoring strategy has been used in previous research as a control condition and was also used to control over the contextual factors (eg, participants’ self-monitoring of sleep and therapist contact) in this study. No therapeutic intervention was given by the research staff during this phase.Outcome measuresThe measures selected for this study focused on three key domains below that provide a detailed clinical profile relevant to COMISA beyond the primary endpoints of the trial, which focused on regular PAP use and insomnia remission.13Sleep parametersStandardized prospective sleep diaries were used to assess self-reported sleep patterns along with a rating of SQ.27 Participants were asked to fill out the diary daily with questions regarding daily sleep pattern, such as “what time did you get into bed?,” “how long did it take you to fall asleep?,” “how many times did you wake up, not counting your final awakening?,” etc, for 7 consecutive days at each assessment point. Diaries with at least 4 days of data were counted as valid and the averages of sleep parameters were calculated at each assessment point. Sleep parameters include SOL, WASO, time in bed (TIB), TST, SE, and SQ. In addition to self-reported sleep, wrist actigraphy (Actiwatch by Phillips Respironics) was used to collect objectively measured sleep.28,29 Scoring of actigraphy data followed a protocol used in previous study (see Figure S2 for scoring protocol). Consistent with diaries, averages for each sleep parameter (ie, SOL, WASO, TIB, TST, and SE) were calculated at each assessment point if there were at least 4 days of valid data.Daytime functioningSeveral self-reported measures were collected to assess the impact of the interventions on daytime functioning. The FOSQ is a 30-item scale that measures the impact of daytime sleepiness on multiple daily activities across 5 subscales (activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcome) with higher scores representing less difficulties in carrying out the activities.30 The ESS is an 8-item scale that measures the general level of daytime sleepiness by assessing the tendency of dozing off/falling asleep under 8 different situations. ESS scores have been found to correlate with the severity of OSA and be responsive to the treatment effects after PAP therapy for OSA.31,32 The Flinders Fatigue Scale (FFS) is a 7-item scale that assesses the extent of insomnia-related fatigue and its impact on everyday functioning.33 Higher scores on both the ESS and FFS indicate greater impairment.Cognitive emotional measuresSeveral cognitive emotional measures were collected to examine changes in cognitions related to insomnia, hyperarousal, and emotional functioning. The Beliefs and Attitudes about Sleep (BAS) is a 30-item scale that assesses dysfunctional beliefs and attitudes about sleep, which might contribute to initiation and persistence of insomnia.34 Questions include unrealistic sleep expectations, perceptions of diminished control over sleep, and beliefs about sleep-promoting behaviors rated from 0 to 10 for each item, with a higher total score indicating greater dysfunctional cognition. The Glasgow Sleep Effort Scale is a 7-item self-report measure of sleep effort during the past week, scored on a 3-point Likert scale, with higher scores indicating greater sleep effort.35 The Sleep Locus of Control is an 8-item, 6-point Likert scale that measures the degree of how much an individual believes his or her sleep experiences are the result of personal control, as opposed to chance or external factors, with a higher scores representing a greater internal locus of control.36 The Pre-Sleep Arousal Scale is a 16-item self-report measure that assesses somatic and cognitive arousal (subscales) in the period prior to sleep.37 This scale uses a 5-point Likert scale to rate the extent to which each item is experienced, with higher scores indicating greater presleep arousal experience. The Center for Epidemiologic Studies Depression is a 20-item scale used to evaluate the level of depressive symptoms.38 The State Trait Anxiety Inventory – Trait is a 20-item scale to measure participants’ trait anxiety.39 Items are scored on a 4-point Likert scale, with higher scores indicating greater anxiety level.Data analysisStatistical analyses were conducted through IBM SPSS Statistics 25 (IBM Corp., Armonk, New York). A two-tailed alpha level of 0.05 was used to determine significance for all statistical tests. A series of 3 (treatment arm) × 4 (time/assessment point) linear mixed models with a nested factor of recruitment site were performed on each outcome measure to examine the effect of CBT-I and PAP treatment combination across assessment points. The models were adjusted for age, educational level (attended graduate school or not), marital status (married or not), sex, OSA severity (mild [AHI ≥ 5 events/h and < 15 events/h] or moderate-to-severe [AHI ≥ 15 events/h]), and average PAP use (average minutes of usage over the 90-day period).This study used a three-arm partial factorial design (see Figure S1). The factorial model was built by treatment type (CBT-I/PAP) × treatment presence (not present/present and delivered first/present and delivered second) and was informed by the combinations that were most relevant to the specific research questions (ie, timing and benefits of CBT-I in addition to PAP).24 To test the relative benefits of each intervention (CBT-I, PAP, or self-monitoring), planned contrast comparisons based on the study’s factorial model were used when significant arm × time interactions were found in linear mixed model analyses (see Table S2 for contrast design). To compare the effect of different treatments, between-assessment point differences of each outcome measure were calculated (eg, time period 1 = score changes from Assessment 1 to 2, period 2 = Assessment 2 to 3). Three arm × 3 time periods were then decomposed into 9 levels (eg, level 1 = Arm A at time period 1, level 2 = Arm A at period 2). By designating contrast weights toward each level, this study extracted specific treatment phases to compare between treatment conditions. A total of 6 special contrasts (including 1 for intercepts) were built in each posttest to examine the relative benefits of each treatment and its combination: (1) Arm A, B vs Arm C (CBT-I + PAP vs PAP-alone); (2) Arm A vs Arm B (the timing of CBT-I initiation); (3) CBT-I vs self-monitoring; (4) PAP vs self-monitoring; and (5) CBT-I vs PAP (see Table S2).In addition, exploratory analyses from the previous main outcome study13 identified significant relationships between certain demographic variables (ie, level of education and marital status) and PAP adherence. To explore the potential impact of demographic factors, OSA severity, and PAP use on nocturnal sleep and daytime performance in COMISA, this study examined the relationships between these covariates and the outcome measures.RESULTSDemographic characteristicsOne hundred eighteen participants were included for final analysis. The mean age was 49.99 ± 13.12 years with a range from 25 to 79 years, with 53.4% of the sample female. As shown in Table 1, no demographic or OSA severity difference was found between treatment arms.Table 1 Sample characteristics.Arm AArm BArm CP(n = 41)(n = 39)(n = 38)Age (M, SD)47.712.653.211.149.215.1.15Sex (n, %).26 Male2151.2%1435.9%2052.6% Female2048.8%2564.1%1847.4%Race (n, %).35 American Indian/Alaskan Native00.0%00.0%12.6% Asian37.3%12.6%37.9% Black or African American1536.6%1948.7%1642.1% White2356.1%1948.7%1642.1% More than one race00.0%00.0%25.3%OSA severity (n, %).99 Mild (AHI ≥ 5 and < 15 events/h)1843.9%1743.6%1642.1% Moderate/severe (AHI ≥ 15 events/h)2356.1%2256.4%2257.9%Education years (M, SD)15.92.915.82.916.43.0.63Marital status (n, %).24 Married1434.2%1025.6%1436.8% Single2151.2%1948.7%2155.3% Divorced37.3%820.5%37.9% Live-in partner12.4%25.1%00.0% Widowed24.9%00.0%00.0%Occupational status (n, %).37 Employed2868.3%2359.0%2463.2% Student24.9%00.0%25.3% Retired512.2%1025.6%615.8% Homemaker00.0%25.1%00.0% Disabled00.0%00.0%12.6% Unemployed614.6%410.3%513.2%PAP use [n, M (SD)], average minutes of use per night38159.58 (135.88)34174.06 (153.34)30223.12 (142.81).18Arm A: Cognitive behavioral therapy for insomnia (CBT-I) in Phase I (baseline to PAP titration) and PAP in Phase II (PAP titration to 90-day assessment); Arm B: self-monitoring in Phase I and CBT-I + PAP in Phase II; Arm C: self-monitoring in Phase I and PAP in Phase II. AHI = apnea-hypopnea index, M = mean, OSA = obstructive sleep apnea, PAP = positive airway pressure, SD = standard deviation.SleepSleep diaryA main effect of time was found on all sleep parameters, indicating that there was a significant decrease across all study arms on SOL (F[3, 81.63] = 8.49, P < .001), WASO (F[3, 96.43] = 14.04, P < .001), and TIB (F[3, 88.97] = 4.58, P = .005) and an increase on TST (F[3, 91.01] = 4.29, P = .007), SE (F[3, 91.49] = 15.68, P < .001), and SQ (F[3, 86.53] = 20.29, P < .001) from baseline (Assessment 1) to end of treatment (Assessment 4) (Table 2). In addition, significant arm × time interactions were found on SOL (F[6, 81.52] = 6.25, P < .001), WASO (F[6, 96.48] = 3.73, P = .002), TIB (F[6, 89.23] = 7.30, P < .001), SE (F[6, 91.40] = 8.48, P < .001), and SQ (F[6, 86.56] = 3.42, P = .004) (see Figure 2A and Figure 3).Table 2 Sleep diary and actigraphy measures of nocturnal sleep at each assessment point by each treatment arm.BaselinePAP Titration30-Day Assessment90-Day AssessmentnM (SD)nM (SD)nM (SD)nM (SD)Sleep diary SOL***†††Arm A3935.08 (24.28)3814.28 (10.85)3218.27 (15.74)3423.37 (23.25)Arm B3842.37 (48.97)3338.16 (44.85)3116.58 (17.81)3016.72 (13.99)Arm C3736.73 (33.30)3426.14 (17.72)2926.53 (23.75)2817.52 (13.44) WASO***††Arm A3947.40 (37.59)3821.06 (26.94)3218.27 (18.64)3423.87 (30.54)Arm B3841.73 (29.33)3347.46 (44.45)3127.25 (36.93)3020.36 (18.77)Arm C3738.77 (25.69)3433.35 (28.74)2920.41 (21.92)2816.94 (13.19) TIB**Δ†††Arm A39464.14 (63.46)38420.57 (59.29)32428.12 (45.93)34464.70 (62.30)Arm B38487.82 (83.38)33494.42 (80.23)31437.90 (73.52)30451.94 (62.13)Arm C37472.54 (83.64)34474.90 (64.16)29489.00 (61.66)28468.10 (62.08) TST**Arm A39352.19 (89.19)38368.78 (76.04)32377.27 (47.13)34405.83 (57.80)Arm B38375.47 (103.64)33379.69 (89.69)31383.46 (77.40)30396.57 (70.48)Arm C37358.01 (87.30)34375.04 (58.42)29402.05 (63.01)28400.65 (53.76) SE***†††Arm A3975.25 (14.83)3887.20 (11.59)3288.40 (7.87)3487.45 (8.34)Arm B3876.83 (16.11)3377.18 (16.03)3187.60 (10.58)3087.83 (8.70)Arm C3775.87 (14.51)3479.44 (10.50)2982.59 (12.44)2885.98 (8.23) SQ*** Δ††Arm A382.92 (0.60)383.29 (0.76)323.48 (0.80)343.44 (0.75)Arm B372.86 (0.78)332.95 (0.67)313.39 (0.67)303.51 (0.72)Arm C372.54 (0.62)342.73 (0.65)293.03 (0.81)283.39 (0.66)Actigraphy SOLArm A3624.20 (25.95)3121.94 (25.40)2413.33 (14.07)2726.91 (37.45)Arm B3031.00 (26.29)2628.51 (37.86)2720.65 (17.67)2320.78 (13.03)Arm C2728.40 (32.53)2837.47 (36.99)2627.00 (21.48)2426.38 (20.38) WASO*Arm A3659.40 (26.37)3147.57 (21.98)2445.56 (27.36)2754.65 (29.38)Arm B3063.66 (28.56)2663.88 (30.09)2754.73 (24.99)2352.48 (22.23)Arm C2755.22 (19.98)2863.12 (26.22)2656.78 (29.27)2452.89 (24.62) TIB**†Arm A36473.28 (68.09)31434.34 (51.41)24435.78 (40.26)27467.01 (61.88)Arm B30499.27 (73.47)26495.88 (82.53)27454.12 (80.12)23462.36 (64.26)Arm C27480.05 (42.92)28478.52 (58.16)26475.54 (63.91)24479.61 (70.56) TSTArm A36369.31 (70.53)31342.43 (60.12)24356.32 (52.71)27366.92 (59.09)Arm B30383.96 (61.70)26381.61 (68.89)27364.08 (73.08)23369.98 (59.44)Arm C27373.29 (47.63)28352.67 (67.31)26371.54 (57.11)24377.39 (59.46) SE*Arm A3678.12 (10.70)3178.69 (10.97)2482.18 (10.50)2779.19 (12.16)Arm B3077.37 (7.74)2677.37 (9.23)2780.45 (8.79)2380.04 (7.02)Arm C2777.20 (9.30)2874.01 (11.29)2678.21 (7.77)2479.10 (8.33)*Significance of the fixed effect of time (assessment points) in the linear mixed models, *P < .05, **P < .01, ***P < .001. ΔSignificance of the fixed effect of arm in the linear mixed models, P < .05. †Significance of arm × time interaction i" @default.
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• W3204993131 title "A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance" @default.
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