Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626048
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Optimizing an Integrated Mind and Body Treatment for Insomnia The SLEEPS Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing an Integrated Mind and Body Treatment for Insomnia The SLEEPS Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLEEPS
Brief Summary:
This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia CBT-I and passive body heating PBH sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder
Detailed Description:
Insomnia disorder is a common and consequential mental health problem with prevalence estimates at approximately 10 The American College of Physicians recommends cognitive behavioral therapy for insomnia CBT-I an efficacious mind psychological and behavioral treatment as the first-line treatment for adults with insomnia Yet about half of individuals experience residual insomnia symptoms after CBT-I Accordingly researchers have sought to augment CBT-I primarily with pharmacotherapy but many people do not want to use pharmacologic agents due to concerns about side effects and dependence Passive-body heating PBH a body treatment involves heating the body via hot baths or showers infrared sauna or other heat sources PBH has been found to reduce the time needed to fall asleep and to improve sleep quality PBH may improve sleep by increasing skin temperature and decreasing core body temperature a dynamic associated with sleep onset CBT-I and PBH thus target distinct factors that may contribute to insomnia and the investigators hypothesize that the combination of CBT-I and PBH holds promise as a multi-component treatment for insomnia disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None