N/A
Completed N=45
Understanding the Sleep Apnea/Insomnia Interaction
Sleep Apnea Syndromes · Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT01824472 ↗
Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Aug 2020
Primary outcomePrimary: Insomnia Severity Index Score — -8.2; -7.33; -6.27 score on a scale — p=0.8
Summary
Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index Score |
-8.2; -7.33; -6.27 | 0.8 |
Eligibility Criteria
Inclusion Criteria
- Sleep Apnea
- Insomnia
- Age >18
Exclusion Criteria
- Sedative/psychoactive drug use recently
- Other clinically significant sleep disorders
- Previous treatment for obstructive sleep apnea (OSA)
- Requires oxygen or bilevel PAP therapy
- Clinically unstable medical condition
- Recent shift work
- Significant alcohol use
- Other clinically significant causes of insomnia
- Illicit drug use
- Prescription stimulants
- Safety restrictions
- Unable to treat sleep apnea with positive airway pressure therapy
- Communication barriers
- Cognitive impairment
Data sourced from ClinicalTrials.gov (NCT01824472). 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.