Web Based CBT-I in Patients With OSA and Insomnia

Not Applicable

Withdrawn

• Conditions: Insomnia; Obstructive Sleep Apnea
• Interventions: Behavioral: web based cognitive-behavioral therapy

• 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.

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-16
• Status Verified: 2021-02
• Study Start: 2021-03-10
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-30
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age ≥18
• Apnea-Hypopnea Index (AHI) ≥5

Exclusion Criteria

• Complex sleep apnea
• AHI >35
• Psychiatric comorbidies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm of CBT-I treatment	web based cognitive-behavioral therapy	Web cognitive behavioral therapy was administered before starting CPAP use by a psychologist expert in behavioral sleep medicine and expert in CBT-I. CBT-I was administered according to the same model and standard visual approach in patients with insomnia. Five sessions are scheduled: sleep psycho-education, sleep restriction, stimulus control, sleep hygiene and challenging beliefs and perception of sleep.
Arm of psycho-education session	web based cognitive-behavioral therapy	Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use

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