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Sleep in Women With Bilateral Salpingo-Oophorectomy

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04565158
Collaborator
(none)
120
Enrollment
1
Location
44.6
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Sleep Disruption in Women With Bilateral Salpingo-Oophorectomy - A SCORE Ancillary Study
    Actual Study Start Date :
    Dec 14, 2020
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Aug 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Women with bilateral salpingo-oophorectomy (BSO)
    Women without bilateral salpingo-oophorectomy (BSO)

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of sleep disorders [2 years]

      prevalence of sleep disordered breathing, insomnia, and restless legs syndrome

    2. prevalence of short sleep duration [2 years]

      objective sleep duration from actigraphy/polysomnography and subjective sleep duration from self-report

    3. prevalence of poor sleep quality [2 years]

      objective sleep quality from actigraphy/polysomnography and subjective sleep quality from self-report

    Other Outcome Measures

    1. exploratory correlation between sleep measures and cognitive function [2 years]

      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. exploratory correlation between sleep measures and neuroimaging [2 years]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women who participate in the parent SCORE studies (NCT03821857)
    Exclusion Criteria:
    • Night shift workers will be excluded

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Naima Covassin, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Naima Covassin, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04565158
    Other Study ID Numbers:
    • 20-005982
    First Posted:
    Sep 25, 2020
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Naima Covassin, Principal Investigator, Mayo Clinic
    salpingo-oophorectomy
    sleep
    cognitive decline

    Study Results

    No Results Posted as of Jan 4, 2022