Not Yet RecruitingNot Applicable

The Sleep-pain Relationship in Women with Endometriosis

60 participantsStarted 2025-03

Plain-language summary

The goal of this study is to examine the sleep-pain relationship in women diagnosed with endometriosis, by monitoring different symptoms of endometriosis and sleep through an experience sample method study (ESM).The main question it aims to answer is: How does sleep impact cyclic and chronic pain and vice versa in women with endometriosis? Participants will be asked to fill in a 6-item diary (twice a day) over the course of 2 months.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult premenopausal women with a laparoscopic and histopathological diagnosis of endometriosis, without a history of hysterectomy, experiencing cyclic or chronic pelvic pain for 3 months or longer, with pain intensity of at least 3 out of 10 over the past 3 months, experiencing non-restorative sleep (defined as a subjective feeling of being unrefreshed up-on awakening) for 3 months or longer, in the absence of elevated risk for intrinsic sleep disorders (such as sleep apnea or restless leg syndrome), and having sufficient knowledge of either French, Dutch, or English Exclusion Criteria: * Participants younger than 18 years old, without laparoscopic and histopathological diagnosis of endometriosis, participants with a hysterectomy or pain intensity lower than 3/10, with restorative sleep or sleep apnea and restless leg syndrome, shift work and insufficient knowledge of either French, Dutch or English.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sleep quality

Timeframe: From enrollment to the end of ESM at 8 weeks

Pain intensity

Timeframe: From enrollment to the end of ESM at 8 weeks

Trial details

NCT IDNCT06834737

SponsorVrije Universiteit Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Zosia Goossens

02 629 25 26 zosia.goossens@vub.be

View on ClinicalTrials.gov More Endometriosis trials