Web Based CBT-I in Patients With OSA and Insomnia
- Conditions
- InsomniaObstructive Sleep Apnea
- Registration Number
- NCT04473534
- Lead Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Brief Summary
Obstructive sleep apnea (OSA) and insomnia often occur in the same patient. Recent studies have demonstrated the efficacy of cognitive behavioral therapy (CBT-I) in patients with insomnia and OSA. Our aim is to verify the efficacy of web based CBT-I in patients with OSA and insomnia and the effect of web based CBT-I on the acceptance and adherence to CPAP (Continuous Positive Airway Pressure) therapy.
- Detailed Description
Obstructive sleep apnea is one of the most common sleep disorders with high prevalence in males sex, is often associated with insomnia. The presence of both sleep disorders generates a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere to CPAP therapy and increase cardiovascular risk. CBT-I is considered the best treatment for insomnia and recent research has demonstrated the efficacy of CBT-I also when insomnia is associated with OSA. After six month of treatment we will test the efficacy of web-based CBT-I in patients with OSA and insomnia in comparison to one session of psycho education on sleep, OSA, insomnia, the interaction among them and the influence on CPAP adherence.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age ≥18
- Apnea-Hypopnea Index (AHI) ≥5
- Complex sleep apnea
- AHI >35
- Psychiatric comorbidies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Insomnia Severity six months of CPAP use Assessed by Insomnia Severity Index
- Secondary Outcome Measures
Name Time Method Adherence to CPAP therapy six months of use Hours of CPAP use during sleep with download of data
Trial Locations
- Locations (1)
Fabio Rossato
🇮🇹Veruno, Novara, Italy
Fabio Rossato🇮🇹Veruno, Novara, Italy