N/A
Completed N=78
CPAP vs ASV for Insomnia
Source: ClinicalTrials.gov NCT02365064 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Insomnia Severity Index — 9.29; 13.21 units on a scale
Summary
The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index |
9.29; 13.21 | — |
| SECONDARY Sleep Quality Rating |
1.06; 1.65 | — |
| SECONDARY Global Morning Rating |
15.39; 24.33 | — |
| SECONDARY Sleep Onset Latency |
-6.09; 7.17 | — |
| SECONDARY Wake After Sleep Onset (WASO) |
5.72; -0.12 | — |
| SECONDARY Sleep Efficiency |
0.75; -2.85 | — |
Eligibility Criteria
Inclusion Criteria
- Primary complaint of insomnia when presenting at clinic
- Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15
- Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine)
- Diagnosis of SDB, either OSA as determined by an AHI ≥ 5 events/hour or UARS with a RDI ≥ 15 events/hour and AHI 30 kg/m2
- Epworth Sleepiness Scale (ESS) score ≥ 10
- Frequent napping behavior, such as a few times a week or more
- Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial
- Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints
- Daily use of opiate medications
- Known contraindications to PAP therapy as listed in the indication for use
- Requires a CPAP (fixed) pressure > 20 cm H2O
- Inability to comply with study procedures
Data sourced from ClinicalTrials.gov (NCT02365064). 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.