Status:
TERMINATED
Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT)
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
SEFAM MEDICAL (Villiers les Nancy, France)
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Continuous positive airway pressure (CPAP) is the first line therapy for Obstructive Sleep Apnea Syndrome (OSAS) but has limited impact for reducing cardio-metabolic risk. Combined treatment strategi...
Detailed Description
"SLEEPCONNECT" is a prospective multicenter observational study with: * Evaluation of the impact of multimodal remote monitoring using connected devices and a dedicated smartphone application on the ...
Eligibility Criteria
Inclusion
- Obstructive sleep apnea syndrome not treated with CPAP and defined by an apnea-hypopnea index (AHI) greater than 15 events per hour and with more than 80% of obstructive events, determined by polysomnography (PSG) or polygraphy (PG) within the last 6 months
- Treated hypertension or newly diagnosed hypertension defined as 140 ≤ SBP \<180 mmHg and 90 ≤ DBP\<110 mmHg
- BMI \> 28 kg / m²
- Smartphone
- Able to use a mobile application on a personal smartphone
- Medical certificate for the practice of physical activity/exercise
- Patients who have freely given their informed written consent
- Person affiliated to the French social security system
Exclusion
- Central sleep apnea syndrome
- Patient with planned bariatric surgery
- Severe bullous emphysema
- Pneumothorax
- Trauma or recent surgery to or affecting the forebrain with sequelae of cranio-naso/pharyngeal fistula
- Decompensated cardiac insufficiency or hypotension, particularly in the event of reduced blood volume or in the case of cardiac arrhythmias
- Dehydration
- Tracheotomy
- Pregnant or lactating women
- Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research project that may impact the study
- Patients under guardianship or curatorship
- Patients not affiliated to the French social security system or equivalent
- Patients deprived of their liberty or hospitalized without their consent
- Major patients protected by law
- Person under administrative or judicial review
- Minor patients
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04054180
Start Date
June 7 2021
End Date
February 28 2024
Last Update
March 6 2024
Active Locations (1)
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1
UniversityHospitalGrenoble
Grenoble, France, 38043