Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT00374192
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 and/or 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, 2002);community-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 (i.e. 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:
NCT00374192
Study Brief:
Protocol Section:
NCT00374192