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Completed

NCT Number: NCT04565158

Sleep in Women With Bilateral Salpingo-Oophorectomy

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.

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Key information

Conditions

Bilateral Salpingo-oophorectomy Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Night shift workers will be excluded

Treatment and study plan

Primary outcomes

  1. prevalence of sleep disorders

    Time frame: 2 years

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

  2. prevalence of short sleep duration

    Time frame: 2 years

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

  3. prevalence of poor sleep quality

    Time frame: 2 years

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

Other outcomes

  1. 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. 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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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