Assessment of the Occurrence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in Women Suffering from Endometriosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorElsan
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Post menopausal patient
Ongoing treatment for OSAHS
Patient with Chronic Obstructive Pulmonary Disease (COPD) or unstabilized cardiac disorders
Concomitant participation in another clinical trial
Trial population
Patients with confirmed endometriosis, that are followed for pain at the site's dedicated pain unit, and who display OSAHS symptoms.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
questionnaires completion
Other interventionPatients 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
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Patients with confirmed Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis1 intervention
Trial outcomes
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
Time frame
12 monthsSecondary outcomes
1
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
Time frame
3, 6 and 12 months2
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
Time frame
3, 6 and 12 months3
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
Time frame
3, 6 and 12 months4
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
Time frame
3, 6 and 12 monthsLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: