Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374192
Status:
COMPLETED
Last Update Posted:
2009-08-10
First Post:
2006-09-08
Brief Title:
The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2009-08
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:
To examine the change in sleep patterns and mood symptoms in response to eszopiclone Lunesta using a double-blind placebo-controlled cross-over study design in perimenopausal and postmenopausal women who experience insomnia mild depression andor anxiety
Detailed Description:
The study design is a double-blinded placebo-controlled cross-over study that will be completed at the MGH site It is an 11-week study of insomnia mild mood and anxiety symptoms in peri- and postmenopausal women age 40 years or older Subjects who are enrolled will have 5 office visits during the 11-week long study
Various studies have identified female gender as a strong risk factor for insomnia Ford Kamerow 1989 Klink et al 1992 Li et al 2002community-based studies that examined gender differences in insomnia complaints have consistently shown a higher prevalence of insomnia among women than among men It has been hypothesized that insomnia might be an overlooked complaint among women seeking treatment in the primary care setting
Insomnia and other sleep disturbances may be reported during specific situations associated with the female reproductive cycle such as pregnancy Sahota et al 2003 and menopause Joffe et al 2003 Complaints of sleep-onset and sleep-maintenance insomnia are among the most common symptoms in peri- and postmenopausal women This sleep disturbance frequently co-occurs with hot flushes and depression symptoms The menopausal transition is also a period of heightened vulnerability to mood and anxiety disturbances and significant vasomotor symptoms ie hot flushes and night sweats which may affect functioning and quality of life
Consented subjects will track their sleep patterns for one week using a sleep diary to confirm that they have either difficulty initiating sleep ³ 30 minutes or difficulty maintaining sleep wake time after sleep onset ³ 30 for 3 nights during 7-day observation period Those who are confirmed to meet these insomnia criteria will be randomized in a 1-to-1 fashion to cross-over treatment starting with either eszopiclone or placebo
In addition to taking the daily medication and coming to the office visits subjects will complete a daily diary throughout the study This diary is completed to assess insomnia symptoms throughout the duration of the study Treatment assignments will be revealed at final study visit to the participant research coordinator and study physician
Various studies have identified female gender as a strong risk factor for insomnia Ford Kamerow 1989 Klink et al 1992 Li et al 2002community-based studies that examined gender differences in insomnia complaints have consistently shown a higher prevalence of insomnia among women than among men It has been hypothesized that insomnia might be an overlooked complaint among women seeking treatment in the primary care setting
Insomnia and other sleep disturbances may be reported during specific situations associated with the female reproductive cycle such as pregnancy Sahota et al 2003 and menopause Joffe et al 2003 Complaints of sleep-onset and sleep-maintenance insomnia are among the most common symptoms in peri- and postmenopausal women This sleep disturbance frequently co-occurs with hot flushes and depression symptoms The menopausal transition is also a period of heightened vulnerability to mood and anxiety disturbances and significant vasomotor symptoms ie hot flushes and night sweats which may affect functioning and quality of life
Consented subjects will track their sleep patterns for one week using a sleep diary to confirm that they have either difficulty initiating sleep ³ 30 minutes or difficulty maintaining sleep wake time after sleep onset ³ 30 for 3 nights during 7-day observation period Those who are confirmed to meet these insomnia criteria will be randomized in a 1-to-1 fashion to cross-over treatment starting with either eszopiclone or placebo
In addition to taking the daily medication and coming to the office visits subjects will complete a daily diary throughout the study This diary is completed to assess insomnia symptoms throughout the duration of the study Treatment assignments will be revealed at final study visit to the participant research coordinator and study physician
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