Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT04473534
Status:
WITHDRAWN
Last Update Posted:
2023-09-29
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web Based CBT-I in Patients With OSA and Insomnia
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Study Overview
Official Title:
Web Based Cognitive-behavioral Therapy in Patients With Obstructive Sleep Apnoea Syndrome and Insomnia: a Randomized Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely becauase of organisational problems.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: