EndometriosisENDOSASNCT06060756
Assessment of the Occurrence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in Women Suffering from Endometriosis
An observational study of Endometriosis and Obstructive Sleep Apnea-hypopnea, run by Elsan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Obstructive Sleep Apnea-hypopnea
- What is being tested?
- questionnaires completion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with confirmed endometriosis, that are followed for pain at the site's dedicated pain unit, and who display OSAHS symptoms.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Endometriosis, Obstructive Sleep Apnea-hypopnea
- Being tested
- questionnaires completion
- Keywords
- observational, Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires completionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: questionnaires completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060756
- Sponsor's protocol ID
- ENDOSAS
- Acronym
- ENDOSAS
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Occurrence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in French Women Suffering from Endometriosis.
- ClinicalTrials.gov ID
- NCT06060756
- Acronym / sponsor ID
- ENDOSAS / ENDOSAS
- Conditions
- Endometriosis, Obstructive Sleep Apnea-hypopnea
- Keywords
- observational, Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Sep 2023 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis | – | Other: questionnaires completionPatients 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with confirmed endometriosis, that are followed for pain at the site's dedicated pain unit, and who display OSAHS symptoms.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| questionnaires completionPatients 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 | Other | Patients with confirmed Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis |
Primary outcome
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)
Time frame: 12 months
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
6 secondary outcomes
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on endometriosis-associated pain
Time frame: 3, 6 and 12 months
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on endometriosis-specific symptoms
Time frame: 3, 6 and 12 months
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on anxiety and depression
Time frame: 3, 6 and 12 months
Assessment of the impact of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) treatment on quality of life
Time frame: 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.
Time frame: 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)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Obstructive Sleep Apnea-hypopnea, run by Elsan.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Mr THOIN, MD (0491159022 ext. +33, fabrice.thoin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2024.