N/A
Completed N=125
Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
Source: ClinicalTrials.gov NCT02027558 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Sleep Quality — 6.25; 9.87 score on a scale — p=<.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Quality |
6.25; 9.87 | <.001 sig |
| PRIMARY Sleep Onset Latency From Sleep Diary |
22.80; 35.77 | 0.013 sig |
| PRIMARY Wake After Sleep Onset From Sleep Diary |
20.42; 40.67 | 0.019 sig |
| PRIMARY Sleep Efficiency From Sleep Diary |
86.24; 75.69 | 0.001 sig |
| PRIMARY Sleep Efficiency From Wrist Actigraphy |
81.70; 78.51 | 0.001 sig |
| PRIMARY PAP Adherence |
38.58; 21.16 | 0.0007 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02027558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.