Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-04
Brief Title:
No More Sleepless Nights in Perimenopause
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
No More Sleepless Nights in Perimenopause - an Open Label Randomized Parallel-group Active Controlled Intervention Study in Perimenopausal Women With Vasomotor Symptoms and Insomnia to Investigate the Efficacy of Hormone Replacement Therapy and Cognitive Behavioral Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the clinical trial is to learn if Hormone Replacement Therapy HRT and Cognitive Behavioral Therapy CBT-I can treat insomnia in menopausal women The main questions it aims to answer are
Are HRT and CBT-I effective in reducing insomnia in menopausal women
Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population
Researchers will compare HRT and CBT-I to an active control group receiving sleep hygiene instructions
Participants will
Complete a screening and baseline assessment
Receive Hormone Replacement Therapy as prescribed Cognitive Behavioral Therapy 1week or sleep hygiene instructions 1week for 8 weeks
Keep a daily diary sleep e-diary to assess sleep-quality
Wear an electroencephalogram EEG during 6 nights 3 at baseline 3 post-intervention to assess deep sleep cycles and waking episodes
Receive a phone call for intervention compliance
Complete a post-intervention assessment
Are HRT and CBT-I effective in reducing insomnia in menopausal women
Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population
Researchers will compare HRT and CBT-I to an active control group receiving sleep hygiene instructions
Participants will
Complete a screening and baseline assessment
Receive Hormone Replacement Therapy as prescribed Cognitive Behavioral Therapy 1week or sleep hygiene instructions 1week for 8 weeks
Keep a daily diary sleep e-diary to assess sleep-quality
Wear an electroencephalogram EEG during 6 nights 3 at baseline 3 post-intervention to assess deep sleep cycles and waking episodes
Receive a phone call for intervention compliance
Complete a post-intervention assessment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None