Bilateral Salpingo-oophorectomyNCT04565158
Sleep in Women With Bilateral Salpingo-Oophorectomy
An observational study of Bilateral Salpingo-oophorectomy, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bilateral Salpingo-oophorectomy
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 6 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Women who participate in the parent SCORE studies (NCT03821857)
Who cannot join
- Night shift workers will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Bilateral Salpingo-oophorectomy
- Keywords
- salpingo-oophorectomy, sleep, cognitive decline
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with bilateral salpingo-oophorectomy (BSO) | Not described | |
| Women without bilateral salpingo-oophorectomy (BSO) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of sleep disorders
prevalence of sleep disordered breathing, insomnia, and restless legs syndrome
Measured: 2 years
prevalence of short sleep duration
objective sleep duration from actigraphy/polysomnography and subjective sleep duration from self-report
Measured: 2 years
prevalence of poor sleep quality
objective sleep quality from actigraphy/polysomnography and subjective sleep quality from self-report
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start14 Dec 2020
- Primary completion30 Oct 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Salpingo-oophorectomyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naima Covassin, Mayo Clinic
- Investigators
- Naima Covassin, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565158
- Sponsor's protocol ID
- 20-005982
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Disruption in Women With Bilateral Salpingo-Oophorectomy - A SCORE Ancillary Study
- ClinicalTrials.gov ID
- NCT04565158
- Acronym / sponsor ID
- 20-005982
- Conditions
- Bilateral Salpingo-oophorectomy
- Keywords
- salpingo-oophorectomy, sleep, cognitive decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with bilateral salpingo-oophorectomy (BSO) | – | – |
| Women without bilateral salpingo-oophorectomy (BSO) | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Women who participate in the parent SCORE studies (NCT03821857)
Key exclusion criteria (1 listed)
- Night shift workers will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of sleep disorders
Time frame: 2 years
prevalence of sleep disordered breathing, insomnia, and restless legs syndrome
prevalence of short sleep duration
Time frame: 2 years
objective sleep duration from actigraphy/polysomnography and subjective sleep duration from self-report
prevalence of poor sleep quality
Time frame: 2 years
objective sleep quality from actigraphy/polysomnography and subjective sleep quality from self-report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naima Covassin, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Salpingo-oophorectomy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of sleep disorders (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.