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Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans

Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02027558
Enrollment
125
Registered
2014-01-06
Start date
2014-01-01
Completion date
2018-01-31
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Apnea

Keywords

cognitive behavioral therapy, insomnia, apnea

Brief summary

The purpose of this study is to determine whether a novel intervention combining cognitive behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence program provided by allied health personnel for older Veterans with obstructive sleep apnea and comorbid insomnia improves nighttime sleep and PAP adherence.

Detailed description

Sleep disturbance is common in older adults and is associated with increased healthcare utilization, more depressive symptoms, and other adverse effects on health-related quality of life. Obstructive sleep apnea (OSA) is a disorder characterized by repetitive episodes of complete or partial upper airway obstruction occurring during sleep. OSA increases in prevalence with age, and is associated with increased risk of cardiovascular disease, decreased quality of life, and increased mortality. Insomnia also increases in prevalence with age, and is associated with numerous adverse outcomes, including cognitive decline, decreased quality of life, increased healthcare costs and increased mortality. The diagnostic criteria for insomnia include a decreased ability to fall asleep or stay asleep, frequent nighttime awakening or poor quality sleep that is associated with daytime impairment such as fatigue, impaired attention, or daytime sleepiness. Increasing evidence suggests that insomnia often coexists with OSA, particularly in older adults, and predicts worse outcomes of OSA. Both OSA and insomnia have a higher prevalence among Veterans, compared to the general population. Little is known of the best approaches to manage the large number of patients with coexisting OSA and comorbid insomnia. Guidelines for best practice typically address these conditions separately, where positive airway pressure (PAP) is the standard for the treatment of OSA, and cognitive behavioral therapy for insomnia (CBT-I) is considered first-line treatment for chronic insomnia. CBT-I is particularly recommended for insomnia in older adults, where adverse effects of sleeping medications are most problematic. Early adherence to PAP therapy (i.e., within the first week of PAP therapy) is one of the strongest predictors of long-term PAP adherence. However, adherence rates to PAP therapy in patients with OSA are low. In addition, CBT-I has not been widely implemented for treatment of insomnia (in part due to limited access to mental health specialists able to provide CBT-I), untreated OSA limits response to treatment of insomnia, and untreated insomnia negatively impacts PAP adherence. Based on this evidence and findings from the investigators' prior work, the investigators believe that an integrated, behavioral treatment approach which addresses both OSA and insomnia early in the course of PAP therapy is needed to maximize patient adherence and treatment success when these conditions coexist. The investigators propose a randomized controlled trial to test a novel, behavioral approach integrating best practices for management of both conditions among older Veterans with OSA who are prescribed PAP therapy and have comorbid insomnia. The purpose of this project is to determine whether this intervention improves nighttime sleep and PAP adherence.

Interventions

BEHAVIORALInsomnia treatment & PAP adherence

Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.

Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Meets diagnostic criteria for insomnia * Diagnosis of obstructive sleep apnea (AHI \> or = 15) and prescription of PAP therapy * Age \> or =50 * Community-dwelling * Live within a 30-mile radius of VA GLAHS * Have transportation to VA GLAHS to attend the intervention/control programs

Exclusion criteria

* Significant cognitive impairment (MMSE \< 24) * History of mania, major psychopathology or a psychiatric hospitalization in prior two years

Design outcomes

Primary

MeasureTime frameDescription
Sleep QualityThree months after randomizationTotal score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Sleep Onset Latency From Sleep DiaryThree months after randomizationSleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Wake After Sleep Onset From Sleep DiaryThree months after randomizationWake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Sleep Efficiency From Sleep DiaryThree months after randomizationSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Sleep Efficiency From Wrist ActigraphyThree months after randomizationSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
PAP AdherenceThree months after randomizationNumber of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
Behavioral Treatment
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence education program provided by allied health personnel in individual sessions.
62
Active Control
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
63
Total125

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath01
Overall StudyLost to Follow-up41
Overall StudyRefused assessment30
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicBehavioral TreatmentTotalActive Control
Age, Continuous62.8 years
STANDARD_DEVIATION 6.7
63.2 years
STANDARD_DEVIATION 7.1
63.7 years
STANDARD_DEVIATION 7.6
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Asian
3 Participants6 Participants3 Participants
Race (NIH/OMB)
Black or African American
14 Participants31 Participants17 Participants
Race (NIH/OMB)
More than one race
4 Participants10 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants6 Participants2 Participants
Race (NIH/OMB)
White
35 Participants69 Participants34 Participants
Sex: Female, Male
Female
1 Participants6 Participants5 Participants
Sex: Female, Male
Male
61 Participants119 Participants58 Participants
Sleep efficiency from sleep diary70.1 percentage of time
STANDARD_DEVIATION 17.8
70.0 percentage of time
STANDARD_DEVIATION 15.9
69.9 percentage of time
STANDARD_DEVIATION 14
Sleep efficiency from wrist actigraphy77.7 percentage of time
STANDARD_DEVIATION 9
77.9 percentage of time
STANDARD_DEVIATION 10
78.1 percentage of time
STANDARD_DEVIATION 10.9
Sleep onset latency from diary40.9 minutes
STANDARD_DEVIATION 41.1
39.3 minutes
STANDARD_DEVIATION 34.7
37.7 minutes
STANDARD_DEVIATION 27.3
Sleep quality11.0 units on a scale
STANDARD_DEVIATION 3.9
11.2 units on a scale
STANDARD_DEVIATION 4.1
11.4 units on a scale
STANDARD_DEVIATION 4.4
Wake after sleep onset from sleep diary53.4 minutes
STANDARD_DEVIATION 49.6
56.0 minutes
STANDARD_DEVIATION 54.2
58.5 minutes
STANDARD_DEVIATION 58.7

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 621 / 63
other
Total, other adverse events
1 / 620 / 63
serious
Total, serious adverse events
0 / 620 / 63

Outcome results

Primary

PAP Adherence

Number of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.

Time frame: Three months after randomization

ArmMeasureValue (MEAN)Dispersion
Behavioral TreatmentPAP Adherence38.58 number of nightsStandard Error 3.89
Active ControlPAP Adherence21.16 number of nightsStandard Error 3.14
p-value: 0.000795% CI: [-27.29, -7.55]t-test, 2 sided
Primary

Sleep Efficiency From Sleep Diary

Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.

Time frame: Three months after randomization

ArmMeasureValue (MEAN)Dispersion
Behavioral TreatmentSleep Efficiency From Sleep Diary86.24 percentage of timeStandard Error 1.69
Active ControlSleep Efficiency From Sleep Diary75.69 percentage of timeStandard Error 1.64
p-value: 0.00195% CI: [4.53, 16.44]Mixed Models Analysis
Primary

Sleep Efficiency From Wrist Actigraphy

Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.

Time frame: Three months after randomization

ArmMeasureValue (MEAN)Dispersion
Behavioral TreatmentSleep Efficiency From Wrist Actigraphy81.70 percentage of timeStandard Error 1.07
Active ControlSleep Efficiency From Wrist Actigraphy78.51 percentage of timeStandard Error 1.07
p-value: 0.00195% CI: [1.87, 6.83]Mixed Models Analysis
Primary

Sleep Onset Latency From Sleep Diary

Sleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.

Time frame: Three months after randomization

ArmMeasureValue (MEAN)Dispersion
Behavioral TreatmentSleep Onset Latency From Sleep Diary22.80 minutesStandard Error 3.86
Active ControlSleep Onset Latency From Sleep Diary35.77 minutesStandard Error 3.74
p-value: 0.01395% CI: [-29.02, -2.49]Mixed Models Analysis
Primary

Sleep Quality

Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.

Time frame: Three months after randomization

ArmMeasureValue (MEAN)Dispersion
Behavioral TreatmentSleep Quality6.25 score on a scaleStandard Error 0.56
Active ControlSleep Quality9.87 score on a scaleStandard Error 0.53
p-value: <0.00195% CI: [-4.58, -1.83]Mixed Models Analysis
Primary

Wake After Sleep Onset From Sleep Diary

Wake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.

Time frame: Three months after randomization

ArmMeasureValue (MEAN)Dispersion
Behavioral TreatmentWake After Sleep Onset From Sleep Diary20.42 minutesStandard Error 4.31
Active ControlWake After Sleep Onset From Sleep Diary40.67 minutesStandard Error 4.16
p-value: 0.01995% CI: [-37.63, -3.29]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026