- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04565158
Sleep in Women With Bilateral Salpingo-Oophorectomy
November 6, 2023 updated by: Naima Covassin, Mayo Clinic
Assessment of Sleep Disruption in Women With Bilateral Salpingo-Oophorectomy - A SCORE Ancillary Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
71
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Cases: Women who underwent bilateral salpingo-oophorectomy prior to natural menopause Controls: Women who did not undergo bilateral salpingo-oophorectomy prior to natural menopause
Description
Inclusion Criteria:
- Women who participate in the parent SCORE studies (NCT03821857)
Exclusion Criteria:
- Night shift workers will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Women with bilateral salpingo-oophorectomy (BSO)
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Women without bilateral salpingo-oophorectomy (BSO)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of sleep disorders
Time Frame: 2 years
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prevalence of sleep disordered breathing, insomnia, and restless legs syndrome
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2 years
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prevalence of short sleep duration
Time Frame: 2 years
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objective sleep duration from actigraphy/polysomnography and subjective sleep duration from self-report
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2 years
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prevalence of poor sleep quality
Time Frame: 2 years
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objective sleep quality from actigraphy/polysomnography and subjective sleep quality from self-report
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2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exploratory correlation between sleep measures and cognitive function
Time Frame: 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 years
|
exploratory correlation between sleep measures and neuroimaging
Time Frame: 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 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Naima Covassin, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2020
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
November 6, 2023
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
September 21, 2020
First Posted (Actual)
September 25, 2020
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-005982
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bilateral Salpingo-oophorectomy
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Washington University School of MedicineNational Cancer Institute (NCI)Completed
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University of California, San FranciscoUniversity of Alabama at BirminghamCompleted
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University of OklahomaCompleted
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Minimally Invasive Devices, Inc.TerminatedCholecystectomy | Benign Hysterectomy | Salingo-oophorectomyUnited States
-
Ciusss de L'Est de l'Île de MontréalMedasense Biometrics LtdCompletedHysterectomy | Gynecologic Laparoscopic Surgery | OophorectomyCanada
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National Cancer Institute (NCI)CompletedHysterectomy | Oophorectomy for Benign ReasonsUnited States
-
Megadyne Medical Products Inc.UnknownAbdominoplasty | Bilateral Breast Reduction | Bilateral Breast Lift | Bilateral Brachioplasty | Bilateral Lateral Thigh and Buttocks LiftUnited States
-
Carolina Eyecare Physicians, LLCAbbott Medical Optics; Science in VisionCompletedCataract Bilateral | Astigmatism BilateralUnited States
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Laurie EisenbergChildren's Hospital Los Angeles; Huntington Medical Research Institutes; Keck...UnknownProfound Bilateral Deafness Due to | Bilateral Cochlear Aplasia | Bilateral Cochlear Nerve Deficiency | Bilateral Cochlear Ossification Secondary to MeningitisUnited States
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Hospices Civils de LyonCompleted