Crawford 2016.
Trial name or title | Evaluating the treatment of obstructive sleep apnoea comorbid with insomnia disorder using an incomplete factorial design |
Methods | Randomised controlled trial (three‐arm) |
Participants | N = 140 (expected); males and females age 18 and over will be considered eligible for this study if they meet criteria for ID and OSA. The presence of OSA will be demonstrated by an Apnea‐Hypopnea Index (AHI) = 5 on a full‐night in‐lab baseline polysomnography (PSG) and 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. Insomnia is characterised by either a complaint of difficulty initiating sleep, maintaining sleep, or waking too early, despite adequate opportunity and circumstances for sleep, coupled with at least one area of significant daytime impairment or distress. In addition, the sleep disturbance will have to be present for at least 3 months. Participants will also have to meet quantitative criteria as evaluated by a sleep diary showing sleep onset latency or wake after sleep onset > 30 minutes, at least 3 nights per week. |
Interventions | Treatment Arm A: receive sequential treatment beginning with CBT‐I followed by PAP, Treatment Arm B: CBT‐I and PAP are administered concurrently, Treatment Arm C: where individuals receive PAP alone. |
Outcomes | PSQI, PAP adherence, ISI (Insomnia Severity Index), daytime sleepiness and fatigue, treatment satisfaction |
Starting date | 2016 |
Contact information | |
Notes | Author correspondence (30 Jan 2019): results have yet to be published as a full manuscript |