Clinical trial NCT06834737: The Sleep-pain Relationship in Women with Endometriosis
Official title: Understanding Endometriosis-related Symptoms and Their Relationship to Sleep
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: ESM
Endometriosis
Sleep
Cyclic pain
Chronic pelvic pain
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep quality
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Pain intensity
timeFrame: From enrollment to the end of ESM at 8 weeks
Secondary outcomes:
measure: Mood
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Stress
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Sleep duration + sleep regulariy
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Fatigue
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Cognitive performance
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Night pain
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Pain frequency
timeFrame: From enrollment to the end of ESM at 8 weeks
Other outcomes:
measure: Menstrual cycle
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Morning/ evening pain
timeFrame: From enrollment to the end of ESM at 8 weeks
measure: Medication intake
timeFrame: From enrollment to the end of ESM at 8 weeks
Locations:
Study officials:
References:
citation: 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.
citation: Arion 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.
citation: Chaichian 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.
citation: Sumbodo 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.