Assessment of the Occurrence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in Women Suffering from Endometriosis (ENDOSAS)

Assessment of the Occurrence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in French Women Suffering from Endometriosis.

This observational study aims at establishing the proportion of patients suffering from endometriosis and for whom an Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis is established.

The study participation will be offered to endometriosis patients displaying symptoms that may suggest an underlying OSAHS.

OSAHS diagnosis will be made according to standard of care practice and patients will be followed up to 12 months after initiating the OSAHS treatment to fill in questionnaires assessing the impact of OSAHS treatment on various endometriosis-related symptoms

Study Overview

• Status: Not yet recruiting
• Conditions: Endometriosis; Obstructive Sleep Apnea-hypopnea
• Intervention / Treatment: Other: questionnaires completion

Detailed Description

The overall prevalence of endometriosis varies between 1% and 8% depending on the studies, and endometriosis would affect approximately one in 10 women in France. In 2022, A report was submitted to the President of the French Republic for the development of a national strategy to fight against endometriosis, proposing in particular the development of a national epidemiological database and an "easily identifiable and accessible diagnosis pathway throughout the territory".

The experience at the investigational site has led to note a significant prevalence of obstructive sleep apnea hypopnea syndrome (OSAHS) in the population of patients with endometriosis. There are no published studies on the relationships between OSAHS and endometriosis. However, intermittent hypoxemia and endothelial dysfunction are two important consequences of OSAHS that may be related to endometriosis. Moreover, it is now accepted that OSAHS is correlated with painful bladder syndrome (interstitial cystitis) and the relationship between endometriosis and a decrease in sleep quality as well as chronic fatigue syndrome has also been demonstrated.

Finally, the benefit of Continuous Positive Airway Pressure (CPAP) treatment on endothelial dysfunction has been demonstrated and, empirically, in cooperation with the investigational site's pain unit, a symptomatic improvement in women with endometriosis and OSAHS after initiation of CPAP treatment was observed.

The study aims at exploring the occurrence of OSAHS in patients with endometriosis followed in the site's dedicated pain unit and the impact of OSAHS treatment when it exists, on the symptoms of endometriosis and quality of life.

OSAHS diagnosis will be made according to standard of care practice in the investigation site. Patients with confirmed diagnosis of OSAHS will be treated according to national recommendations for this disease (CPAP or alternative treatments) and will complete questionnaires at 3, 6 and 12 months after start of OSAHS treatment to assess the impact of OSAHS treatment on various endometriosis-related symptoms.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Fabrice Mr THOIN, MD; Phone Number: +33 0491159022; Email: fabrice.thoin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed endometriosis, that are followed for pain at the site's dedicated pain unit, and who display OSAHS symptoms.

Description

Inclusion Criteria:

• Female patients aged between 18 and 50 years of age
• Confirmed diagnostic of endometriosis (either through imaging procedure (ultrasound or RMI) or diagnostic coelioscopy)
• Patient suffering from symptoms evocating Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and justifying a diagnosis process performed within Standard of Care practice
• Patient who has been informed about the study and has signed the informed consent form prior to any study-specific procedures
• Patient willing and able to perform all scheduled procedures in accordance with the study protocol

Exclusion Criteria:

• Post menopausal patient
• Ongoing treatment for OSAHS
• Patient with Chronic Obstructive Pulmonary Disease (COPD) or unstabilized cardiac disorders
• Concomitant participation in another clinical trial
• Pregnant or breastfeeding woman
• Patient under legal protection measure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with confirmed Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis; Patients from site's pain unit with confirmed OSAHS diagnosis. OSAHS diagnosis will be made according to standard of care practice in the investigation site, through polysomnography and Epworth Sleepiness Scale (ESS).	Other: questionnaires completion; Patients will complete the following questionnaires at 3, 6 and 12 months after start of the treatment for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS): Pain-related questionnaire; Endometriosis-specific questionnaire; Hospital Anxiety and Depression scale; Questionnaire McGill on Quality Of Life; Insomnia-related questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of patients suffering from endometriosis, followed in the site's dedicated pain unit, and who are diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)	The diagnosis of OSAHS will be performed as per standard of care procedures (medical assessment and polysomnography).Patients with confirmed OSAHS diagnosis will be accounted for the study as positive (Yes) for the primary endpoint. Patients who are not diagnosed with OSAHS will be accounted for the study as Negative (No) for the primary endpoint and will discontinue from the study without being followed up to 12 months in the study	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on endometriosis-associated pain	Patients with confirmed OSAHS diagnosis will complete Pain-related questionnaire at 3, 6 and 12 months after start of OSAHS treatment	3, 6 and 12 months
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on endometriosis-specific symptoms	Patients with confirmed OSAHS diagnosis will complete Endometriosis-specific questionnaire at 3, 6 and 12 months after start of OSAHS treatment	3, 6 and 12 months
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on anxiety and depression	Patients with confirmed OSAHS diagnosis will complete Hospital Anxiety and Depression scale at 3, 6 and 12 months after start of OSAHS treatment	3, 6 and 12 months
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on quality of life	Patients with confirmed OSAHS diagnosis will complete the Questionnaire McGill on Quality Of Life at 3, 6 and 12 months after start of OSAHS treatment	3, 6 and 12 months
Exploration of the correlation between answers to the Insomnia-related questionnaire and the sleep disorders objectified by the nocturnal recordings.	Patients with confirmed OSAHS diagnosis will complete Insomnia Severity Index questionnaire at 3, 6 and 12 months after start of OSAHS treatment	3, 6 and 12 months
Exploration of the relationship between cardiological symptoms (palpitations, malaise, chest pain) and the existence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)	Cardiological symptoms occurrence (palpitations, malaise, chest pain) will be assessed from baseline up to the end of study.	12 months

Collaborators and Investigators

• Sponsor: Elsan

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Endometriosis; observational
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Endometriosis
• Other Study ID Numbers: ENDOSAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No