Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454441
Status:
COMPLETED
Last Update Posted:
2007-03-30
First Post:
2007-03-28
Brief Title:
Sleep Quality in CHIMES MF101
Sponsor:
Bionovo
Organization:
Bionovo
Study Overview
Official Title:
Sleep Quality in CHIMES MF101
Status:
COMPLETED
Status Verified Date:
2007-03
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:
Menopausal women often complain of difficulty sleeping and the transition from pre- to postmenopausal status is associated with an incresase in self-reported sleep disturbance Hot flashes have been associated with self-reported measures of sleep disturbance and changes in sleep pattern as measured by plysomnography including an increase in stage 4 and a latency or shortened time in rapid-eye movement sleep Although there are some data on the effect of hormone replacement therapy on self-reported sleep measures in symptomatic postmenopausal women there are no data on the effect of herbal extracts on subjective or objective measures of sleep quality in this population group Actigraphy the use of a device to record movement generally placed on the wrist has been used over 20 years to provide objective data concerning sleepwake patterns The advantage of actigraphy over traditional polysomnography is that actigraphy can conveniently record continuously for 24-hours a day for longer periods of time
Detailed Description:
Specific Aims
1 To determine the effect of MF101 a combination of Chinese herbs compared to placebo on change in sleep quality utilizing baseline and follow-up actigraphy obtained from a subset of approximately 90 women enrolled in the randomized double-blind placebo-controlled Chinese Herbs for Menopausal Symptoms CHIMES trial
2 TO identify the correlates of sleep quality as assessed by actigraphy in women with frequent hot flashes We will evaluate demographic lifestyle anthropometric medical and gynecologic history and hormonal factors that may relate to the actigraphic measures of sleep quality including self-reported measures of sleep
1 To determine the effect of MF101 a combination of Chinese herbs compared to placebo on change in sleep quality utilizing baseline and follow-up actigraphy obtained from a subset of approximately 90 women enrolled in the randomized double-blind placebo-controlled Chinese Herbs for Menopausal Symptoms CHIMES trial
2 TO identify the correlates of sleep quality as assessed by actigraphy in women with frequent hot flashes We will evaluate demographic lifestyle anthropometric medical and gynecologic history and hormonal factors that may relate to the actigraphic measures of sleep quality including self-reported measures of sleep
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