EndometriosisENDONCT06834737
The Sleep-pain Relationship in Women with Endometriosis
A study testing ecological sampling method in people with Endometriosis, run by Vrije Universiteit Brussel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- ecological sampling method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Understanding Endometriosis-related Symptoms and Their Relationship to Sleep
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.
- Conditions
- Endometriosis
- Being tested
- ecological sampling method
- Keywords
- ESM, Endometriosis, Sleep, Cyclic pain, Chronic pelvic pain
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ecological sampling methodOther
6-item diary, twice a day, over the course of 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Cyclic pain | Other | Women eligible for the study are adult, non-(post)menopausal individuals who have received a laparoscopic and histopathological diagnosis of en-dometriosis. They have been experiencing cyclic pain (before, during, and/or after menstruation or monthly flare-ups without menstruation) for at least two months. Participants do not expect to undergo gynecologic or other surgical procedures for en-dometriosis during the study period and are not pregnant or breastfeeding. They must have no external factors interfering with their sleep for three or more nights per week, such as work, noise, or caregiving responsibilities.
intervention: 6 item diary twice a day over the course of 2 months. Receives: Other: ecological sampling method |
| Non-cyclical pain | Other | Women eligible for the study are adult, non-(post)menopausal individuals who have received a laparoscopic and histopathological diagnosis of en-dometriosis. They have been experiencing non-cyclic pain for at least six months. Participants do not expect to undergo gynecologic or other surgical procedures for en-dometriosis during the study period and are not pregnant or breastfeeding. They must have no external factors interfering with their sleep for three or more nights per week, such as work, noise, or caregiving responsibilities.
intervention: 6 item diary twice a day over the course of 2 months. Receives: Other: ecological sampling method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Morning assessment: Irrespective of how much you slept, how good was the quality of your sleep? (0= not at all, 7= very good).
Measured: From enrollment to the end of ESM at 8 weeks
Pain intensity
Evening assessment: How much pain did you experience today? (0= none, 7= very much)
Measured: From enrollment to the end of ESM at 8 weeks
Secondary outcomes (7)
Mood
Evening assessment:
How good was your mood overall today? (0= No good mood at all, 7= very good)
Measured: From enrollment to the end of ESM at 8 weeks
Stress
Evening assessment:
How much stress did you experience today? (0= none, 7= very much)
Measured: From enrollment to the end of ESM at 8 weeks
Sleep duration + sleep regulariy
Morning assessment:
- What time did you go to bed last night?
- What time did you wake up this morning?
- For how long were you awake during the night?
Sleep duration will be calculated based on Q1,Q2,Q3. Sleep regularity will be calculated based on Q1, Q2.
Measured: From enrollment to the end of ESM at 8 weeks
Fatigue
Evening assessment:
How fatigued were you today? (0= Not at all, 7= very fatigued)
Measured: From enrollment to the end of ESM at 8 weeks
Cognitive performance
Evening assessment:
How well do you think you performed cognitively today? (0= Not at all, 7= very good)
Measured: From enrollment to the end of ESM at 8 weeks
Night pain
Morning assessment: How much pain did you experience last night? (0= none, 7= very much)
Measured: From enrollment to the end of ESM at 8 weeks
Pain frequency
Evening assessment: How often did you experience pain today? (0 = not at all, 7 = continuous)
Measured: From enrollment to the end of ESM at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Mairesse, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834737
- Sponsor's protocol ID
- 2526_ENDO
- Acronym
- ENDO
- Status last verified
- Jan 2025
- First submitted
- 13 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunes FR, Ferreira JM, Bahamondes L. Pain threshold and sleep quality in women with endometriosis. Eur J Pain. 2015 Jan;19(1):15-20. doi: 10.1002/ejp.514. Epub 2014 Apr 14.
PubMed 24733758Arion K, Orr NL, Noga H, Allaire C, Williams C, Bedaiwy MA, Yong PJ. A Quantitative Analysis of Sleep Quality in Women with Endometriosis. J Womens Health (Larchmt). 2020 Sep;29(9):1209-1215. doi: 10.1089/jwh.2019.8008. Epub 2020 Mar 13.
PubMed 32176592Chaichian S, Mehdizadehkashi A, Haghgoo A, Ajdary M, Derakhshan R, Rokhgireh S, Sarhadi S, Nikfar B. Sleep disorders in patients with endometriosis; a cross-sectional study. BMC Womens Health. 2024 Jun 14;24(1):340. doi: 10.1186/s12905-024-03185-x.
PubMed 38877485Sumbodo CD, Tyson K, Mooney S, Lamont J, McMahon M, Holdsworth-Carson SJ. The relationship between sleep disturbances and endometriosis: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2024 Feb;293:1-8. doi: 10.1016/j.ejogrb.2023.12.010. Epub 2023 Dec 9.
PubMed 38091847
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Endometriosis-related Symptoms and Their Relationship to Sleep
- ClinicalTrials.gov ID
- NCT06834737
- Acronym / sponsor ID
- ENDO / 2526_ENDO
- Conditions
- Endometriosis
- Keywords
- ESM, Endometriosis, Sleep, Cyclic pain, Chronic pelvic pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Feb 2025 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclic pain | Other | Other: ecological sampling methodWomen eligible for the study are adult, non-(post)menopausal individuals who have received a laparoscopic and histopathological diagnosis of en-dometriosis. They have been experiencing cyclic pain (before, during, and/or after menstruation or monthly flare-ups without menstruation) for at least two months. Participants do not expect to undergo gynecologic or other surgical procedures for en-dometriosis during the study period and are not pregnant or breastfeeding. They must have no external factors interfering with their sleep for three or more nights per week, such as work, noise, or caregiving responsibilities. intervention: 6 item diary twice a day over the course of 2 months. |
| Non-cyclical pain | Other | Other: ecological sampling methodWomen eligible for the study are adult, non-(post)menopausal individuals who have received a laparoscopic and histopathological diagnosis of en-dometriosis. They have been experiencing non-cyclic pain for at least six months. Participants do not expect to undergo gynecologic or other surgical procedures for en-dometriosis during the study period and are not pregnant or breastfeeding. They must have no external factors interfering with their sleep for three or more nights per week, such as work, noise, or caregiving responsibilities. intervention: 6 item diary twice a day over the course of 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ecological sampling method6-item diary, twice a day, over the course of 2 months. | Other | Cyclic pain, Non-cyclical pain |
Primary outcome
Sleep quality
Time frame: From enrollment to the end of ESM at 8 weeks
Morning assessment: Irrespective of how much you slept, how good was the quality of your sleep? (0= not at all, 7= very good).
Pain intensity
Time frame: From enrollment to the end of ESM at 8 weeks
Evening assessment: How much pain did you experience today? (0= none, 7= very much)
7 secondary outcomes
Mood
Time frame: From enrollment to the end of ESM at 8 weeks
Stress
Time frame: From enrollment to the end of ESM at 8 weeks
Sleep duration + sleep regulariy
Time frame: From enrollment to the end of ESM at 8 weeks
Fatigue
Time frame: From enrollment to the end of ESM at 8 weeks
Cognitive performance
Time frame: From enrollment to the end of ESM at 8 weeks
Night pain
Time frame: From enrollment to the end of ESM at 8 weeks
Pain frequency
Time frame: From enrollment to the end of ESM at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 24733758Nunes FR, Ferreira JM, Bahamondes L. Pain threshold and sleep quality in women with endometriosis. Eur J Pain. 2015 Jan;19(1):15-20. doi: 10.1002/ejp.514. Epub 2014 Apr 14.
- Background: PubMed 32176592Arion K, Orr NL, Noga H, Allaire C, Williams C, Bedaiwy MA, Yong PJ. A Quantitative Analysis of Sleep Quality in Women with Endometriosis. J Womens Health (Larchmt). 2020 Sep;29(9):1209-1215. doi: 10.1089/jwh.2019.8008. Epub 2020 Mar 13.
- Background: PubMed 38877485Chaichian S, Mehdizadehkashi A, Haghgoo A, Ajdary M, Derakhshan R, Rokhgireh S, Sarhadi S, Nikfar B. Sleep disorders in patients with endometriosis; a cross-sectional study. BMC Womens Health. 2024 Jun 14;24(1):340. doi: 10.1186/s12905-024-03185-x.
- Background: PubMed 38091847Sumbodo CD, Tyson K, Mooney S, Lamont J, McMahon M, Holdsworth-Carson SJ. The relationship between sleep disturbances and endometriosis: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2024 Feb;293:1-8. doi: 10.1016/j.ejogrb.2023.12.010. Epub 2023 Dec 9.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Questions about this trial
What is this clinical trial studying?
A study testing ecological sampling method in people with Endometriosis, run by Vrije Universiteit Brussel.
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: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zosia Goossens (02 629 25 26, zosia.goossens@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: From enrollment to the end of ESM at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834737, which also lists 4 linked publications.
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 Feb 2025.