Sleep in Women With Bilateral Salpingo-Oophorectomy

Bilateral Salpingo-oophorectomy Clinical Trial

Official title:

Assessment of Sleep Disruption in Women With Bilateral Salpingo-Oophorectomy - A SCORE Ancillary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565158
• Other study ID #: 20-005982
• Status: Completed
• Start date: December 14, 2020
• Est. completion date: November 6, 2023

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research study is the compare objective and subjective sleep characteristics in women who have undergone removal of both ovaries (bilateral salpingo-oophorectomy) before natural menopause compared to women who did not undergo this procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 6, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Women who participate in the parent SCORE studies (NCT03821857)

Exclusion Criteria:

• Night shift workers will be excluded

Related Conditions & MeSH terms

• Bilateral Salpingo-oophorectomy

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	exploratory correlation between sleep measures and cognitive function	correlation between objective and subjective sleep measures (sleep duration, sleep quality and sleep disorders) and tests of cognitive function (attention, memory, language, and global cognitive function)	2 years
Other	exploratory correlation between sleep measures and neuroimaging	correlation between objective and subjective sleep measures (sleep duration, sleep quality and sleep disorders) and tests of cognitive function (attention, memory, language, and global cognitive function)	2 years
Primary	prevalence of sleep disorders	prevalence of sleep disordered breathing, insomnia, and restless legs syndrome	2 years
Primary	prevalence of short sleep duration	objective sleep duration from actigraphy/polysomnography and subjective sleep duration from self-report	2 years
Primary	prevalence of poor sleep quality	objective sleep quality from actigraphy/polysomnography and subjective sleep quality from self-report	2 years

External Links

•   Mayo Clinic Clinical Trials