Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT) (SLEEPCONNECT)

March 4, 2024 updated by: University Hospital, Grenoble

Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)

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 strategies including physical activity and weight loss management have emerged in association with CPAP. Patient's engagement might be supported by connected devices and smartphone applications measuring physical activity, blood pressure, weight and sleep duration. Data fusion of these parameters with CPAP-remote telemonitoring will allow personalized coaching and integrated care of OSAS with cardio-metabolic co-morbidities.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 control of blood pressure after 3 months of CPAP.
  • Evaluation of impact of such an integrated care on physical activity and body weight

This study is supported by the S.BOXTM CPAP device and its companion connected devices (physical activity, blood pressure, sleep duration, weight) and smartphone application collecting CPAP telemonitoring and assessing patients reported outcomes (PROMs). Patients have a continuous access to their own data.

Digital health system will be complemented by physical activity and nutrition coaching. Coaching persons will be inform during the follow-up by data collected by connected devices and app.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38043
        • UniversityHospitalGrenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP S.Box associated with its 3 connected devices
S.BOXTM CPAP associated with its 3 connected devices Each patient will be monitored by a CPAP S.Box, with a Sefam Access application installed on their Smartphone to collect data from 3 connected measuring devices: PROMs, an activity monitor and a blood pressure monitor.
Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor
CPAP associated with connected devices: blood pressure monitor , PROMs and activity monitor Patients will use their connected devices for one year. Data from the connected devices will be transmitted to their smartphone application Sefam Access. At the beginning of the study, patients will have a dietary assessment and start a support program for nutrition counselling and physical activity. At each study visit the dietician and physical exercise coach will give the patient advices on diet and for adjusting physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of mean value of 18 self measures blood pressure
Time Frame: baseline and 3 months

Patients will have a connected blood pressure monitor and will make self-measurements at inclusion and 3 months after starting CPAP.

Self-measurement consists of 3 measurements, with a 1 minute interval between each one, each morning and evening over 3 days.
baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of variability of 18 measurements of SBP by self-measurement, between inclusion and after 3 months of CPAP treatment
Time Frame: baseline to 3 months
Patients will have a connected blood pressure monitor and will be asked to make self-measurements at baseline and at 15 days, 1 month, 2 months, and 3 months after starting CPAP.
baseline to 3 months
Comparison of variability of 18 measurements of DBP by self-measurement, between inclusion and after 3 months of CPAP treatment
Time Frame: baseline to 3 months
Patients will have a connected blood pressure monitor and will be asked to make self-measurements at baseline and at 15 days, 1 month, 2 months, and 3 months after starting CPAP.
baseline to 3 months
Comparison of variability of 18 measurements of mean blood pressure by self-measurement, between inclusion and after 3 months of CPAP treatment
Time Frame: baseline to 3 months
Patients will have a connected blood pressure monitor and will be asked to make self-measurements at baseline and at 15 days, 1 month, 2 months, and 3 months after starting CPAP.
baseline to 3 months
Comparison of number of steps measured before initiating CPAP and at 3 months
Time Frame: baseline and 3 months
Patients will be required to wear their connected activity monitor for one week at inclusion, and 3 months of CPAP treatment.
baseline and 3 months
Evaluation of change in biological laboratory parameters
Time Frame: baseline and 3 months
Comparison of fasting glucose between baseline and after 3 months of CPAP treatment
baseline and 3 months
Evaluation of change in biological laboratory parameters
Time Frame: baseline and 3 months
Comparison of lipid profile between baseline and after 3 months of CPAP treatment
baseline and 3 months
Weight variation over three months
Time Frame: baseline and 3 months
Weight will be recorded using their connected devices at baseline, and 3 months of CPAP treatment.
baseline and 3 months
Assessment of reasons for refusal of digital health by a dedicated questionnaire conducted in patients who refused to participate in the study
Time Frame: baseline
Thirteen questions about: sex, age, professional status, employment situation, smartphone usages, frequency of smartphone use, connected devices and opinions on this.
baseline
Comparison of residual AHI between Polylink respiratory polygraphic data and AHI measurement by CPAP S.Box
Time Frame: 24 hours
After 3 months of treatment by CPAP the patient will have a home polygraphy using the Polylink polygraph
24 hours
Analysis of responses to a specific usability questionnaire
Time Frame: 3 months
Eight questions for each connected device and the smartphone application : Level of difficulty in using the connected devices and application? Level of clarity of instructions for use of these connected devices? How much benefit is there from using this type of connected device? Would the patient be willing to pay € 50 or € 100 to keep the device after the study? Does the patient feel confident using connected devices? Has the association of these devices connected to CPAP been proven beneficial? Does the patient think it is necessary to associate connected devices in the management of OSAS? Does the functionality of 3 connected objects and the Sefam Access smartphone application meet the patient's requirements?
3 months
Epworth sleepiness scale (ESS)
Time Frame: baseline and 3 months
The ESS is a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 sub-item scores( 0-3) can range from 0 to 24. The higher the ESS score the greater the likelihood that the person has daytime sleepiness. The questionnaire takes no more than 2 or 3 minutes to answer.
baseline and 3 months
Pichot fatigue scale (PWS)
Time Frame: baseline and 3 months
This is a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 5-point scale (0-4), any habitual feeling of tiredness or weakness while engaged in eight different activities. The Pichot score (the sum of the 8 item sub-scores (0-4) can range from 0 to 32.The higher the score, the more likely that the person suffers from fatigue/ chronic tiredness. The questionnaire takes no more than 2 or 3 minutes to answer.
baseline and 3 months
Assessment of health-related quality of life using the EQ-5D questionnaire
Time Frame: baseline and 3 months
This questionnaire covers five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scores for these five dimensions can be presented as a health profile or can be converted to a single summary index number
baseline and 3 months
Analysis of all primary and secondary outcome measures at 1 year
Time Frame: 1 year

At the end of the first 3 months of the study, the connected devices will be left for the patients who will be encouraged to continue using them.

Reminders will be sent via the via Sefam Access application at 6, 9 and 12 months to encourage the patient to weigh themselves self, measure their blood pressure and to wear their Actimeter (activity monitor)for 1 week.
1 year
Predictive factors of CPAP adherence at three-months
Time Frame: 3 months
Compliance data on CPAP use will be automatically collected by CPAP telemonitoring
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

SEFAM MEDICAL (Villiers les Nancy, France)

Investigators

  • Principal Investigator: Jean-Louis JLP Pépin, PhD, University Hospital, Grenoble
  • Principal Investigator: Dany DJ Jaffuel, MD, University Hospital, Montpellier
  • Principal Investigator: Thibaut TG Gentina, MD, Clinique de la Louvière SELARL SPIRAL, Lille
  • Principal Investigator: Frédéric FG Gagnadoux, PhD, University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC18.338

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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