Back to resultsMultimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT) (SLEEPCONNECT)
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP associated with connected devices: blood pressure monitor , scales and activity monitor
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea Syndrome focused on measuring Continuous positive airway pressure, Connected devices
Eligibility Criteria
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
Sites / Locations
- UniversityHospitalGrenobleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CPAP S.Box associated with its 3 connected devices
Arm Description
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.
Outcomes
Primary Outcome Measures
Comparison of mean value of 18 self measures blood pressure
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.
Secondary Outcome Measures
Comparison of variability of 18 measurements of SBP by self-measurement, between inclusion and after 3 months of CPAP treatment
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.
Comparison of variability of 18 measurements of DBP by self-measurement, between inclusion and after 3 months of CPAP treatment
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.
Comparison of variability of 18 measurements of mean blood pressure by self-measurement, between inclusion and after 3 months of CPAP treatment
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.
Comparison of number of steps measured before initiating CPAP and at 3 months
Patients will be required to wear their connected activity monitor for one week at inclusion, and 3 months of CPAP treatment.
Evaluation of change in biological laboratory parameters
Comparison of fasting glucose between baseline and after 3 months of CPAP treatment
Evaluation of change in biological laboratory parameters
Comparison of lipid profile between baseline and after 3 months of CPAP treatment
Weight variation over three months
Weight will be recorded using their connected devices at baseline, and 3 months of CPAP treatment.
Assessment of reasons for refusal of digital health by a dedicated questionnaire conducted in patients who refused to participate in the study
Thirteen questions about: sex, age, professional status, employment situation, smartphone usages, frequency of smartphone use, connected devices and opinions on this.
Comparison of residual AHI between Polylink respiratory polygraphic data and AHI measurement by CPAP S.Box
After 3 months of treatment by CPAP the patient will have a home polygraphy using the Polylink polygraph
Analysis of responses to a specific usability questionnaire
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?
Epworth sleepiness scale (ESS)
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.
Pichot fatigue scale (PWS)
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.
Assessment of health-related quality of life using the EQ-5D questionnaire
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
Analysis of all primary and secondary outcome measures at 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.
Predictive factors of CPAP adherence at three-months
Compliance data on CPAP use will be automatically collected by CPAP telemonitoring
Full Information
NCT ID
NCT04054180
First Posted
July 29, 2019
Last Updated
November 3, 2022
Sponsor
University Hospital, Grenoble
Collaborators
SEFAM MEDICAL (Villiers les Nancy, France)
1. Study Identification
Unique Protocol Identification Number
NCT04054180
Brief Title
Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT)
Acronym
SLEEPCONNECT
Official Title
Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 7, 2023 (Anticipated)
Study Completion Date
September 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
SEFAM MEDICAL (Villiers les Nancy, France)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Continuous positive airway pressure, Connected devices
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, open, multicentric, national and uncontrolled study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP S.Box associated with its 3 connected devices
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CPAP associated with connected devices: blood pressure monitor , scales and activity monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of mean value of 18 self measures blood pressure
Description
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.
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
Comparison of variability of 18 measurements of SBP by self-measurement, between inclusion and after 3 months of CPAP treatment
Description
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.
Time Frame
baseline to 3 months
Title
Comparison of variability of 18 measurements of DBP by self-measurement, between inclusion and after 3 months of CPAP treatment
Description
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.
Time Frame
baseline to 3 months
Title
Comparison of variability of 18 measurements of mean blood pressure by self-measurement, between inclusion and after 3 months of CPAP treatment
Description
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.
Time Frame
baseline to 3 months
Title
Comparison of number of steps measured before initiating CPAP and at 3 months
Description
Patients will be required to wear their connected activity monitor for one week at inclusion, and 3 months of CPAP treatment.
Time Frame
baseline and 3 months
Title
Evaluation of change in biological laboratory parameters
Description
Comparison of fasting glucose between baseline and after 3 months of CPAP treatment
Time Frame
baseline and 3 months
Title
Evaluation of change in biological laboratory parameters
Description
Comparison of lipid profile between baseline and after 3 months of CPAP treatment
Time Frame
baseline and 3 months
Title
Weight variation over three months
Description
Weight will be recorded using their connected devices at baseline, and 3 months of CPAP treatment.
Time Frame
baseline and 3 months
Title
Assessment of reasons for refusal of digital health by a dedicated questionnaire conducted in patients who refused to participate in the study
Description
Thirteen questions about: sex, age, professional status, employment situation, smartphone usages, frequency of smartphone use, connected devices and opinions on this.
Time Frame
baseline
Title
Comparison of residual AHI between Polylink respiratory polygraphic data and AHI measurement by CPAP S.Box
Description
After 3 months of treatment by CPAP the patient will have a home polygraphy using the Polylink polygraph
Time Frame
24 hours
Title
Analysis of responses to a specific usability questionnaire
Description
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?
Time Frame
3 months
Title
Epworth sleepiness scale (ESS)
Description
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.
Time Frame
baseline and 3 months
Title
Pichot fatigue scale (PWS)
Description
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.
Time Frame
baseline and 3 months
Title
Assessment of health-related quality of life using the EQ-5D questionnaire
Description
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
Time Frame
baseline and 3 months
Title
Analysis of all primary and secondary outcome measures at 1 year
Description
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.
Time Frame
1 year
Title
Predictive factors of CPAP adherence at three-months
Description
Compliance data on CPAP use will be automatically collected by CPAP telemonitoring
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Louis JLP Pépin, PhD
Phone
+33 4 76 76 84 73
Ext
+33
Email
jpepin@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Corinne CL Loiodice
Phone
+33 4 76 76 84 74
Ext
+33
Email
cloiodice@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis JLP Pépin, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dany DJ Jaffuel, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thibaut TG Gentina, MD
Organizational Affiliation
Clinique de la Louvière SELARL SPIRAL, Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédéric FG Gagnadoux, PhD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis JP Pépin, PhD
Phone
+33 4 76 76 84 73
Ext
+33
Email
jpepin@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Corinne CL Loiodice
Phone
+ 4 76 76 84 74
Ext
+33
Email
cloiodice@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jean-Louis JP Pépin, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
27188535
Citation
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PubMed Identifier
19404644
Citation
Arnaud C, Dematteis M, Pepin JL, Baguet JP, Levy P. Obstructive sleep apnea, immuno-inflammation, and atherosclerosis. Semin Immunopathol. 2009 Jun;31(1):113-25. doi: 10.1007/s00281-009-0148-5. Epub 2009 Apr 29.
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Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT)
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