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

NCT06060756 | Not Yet Recruiting

• 1 other identifier: ENDOSAS
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Endometriosis; Obstructive Sleep Apnea-hypopnea

Keywords

observational; Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on endometriosis-associated pain

  3, 6 and 12 months

• Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on endometriosis-specific symptoms

  3, 6 and 12 months

• Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on anxiety and depression

  3, 6 and 12 months

• Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on quality of life

  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.

  3, 6 and 12 months

Study Arms (1)

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

Interventions

questionnaires completion OTHER

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

Patients with confirmed Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Fabrice Mr THOIN, MD

CONTACT

0491159022; fabrice.thoin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 5, 2024

Record last verified: 2024-09