Obstructive Sleep Apnea SyndromeSLEEPCONNECTNCT04054180
Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT)
A study testing CPAP associated with connected devices: blood pressure monitor , scales and activity monitor in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- CPAP associated with connected devices: blood pressure monitor , scales and activity monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 28 Feb 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- CPAP associated with connected devices: blood pressure monitor , scales and activity monitor
- Keywords
- Continuous positive airway pressure, Connected devices
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP associated with connected devices: blood pressure monitor , scales and activity monitorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CPAP S.Box associated with its 3 connected devices | Experimental | 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. Receives: Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 months
Secondary outcomes (15)
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.
Measured: baseline to 3 months
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.
Measured: 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
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.
Measured: baseline to 3 months
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.
Measured: baseline and 3 months
Evaluation of change in biological laboratory parameters
Comparison of fasting glucose between baseline and after 3 months of CPAP treatment
Measured: baseline and 3 months
Evaluation of change in biological laboratory parameters
Comparison of lipid profile between baseline and after 3 months of CPAP treatment
Measured: baseline and 3 months
Weight variation over three months
Weight will be recorded using their connected devices at baseline, and 3 months of CPAP treatment.
Measured: 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
Thirteen questions about: sex, age, professional status, employment situation, smartphone usages, frequency of smartphone use, connected devices and opinions on this.
Measured: baseline
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
Measured: 24 hours
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?
Measured: 3 months
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.
Measured: baseline and 3 months
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.
Measured: baseline and 3 months
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
Measured: baseline and 3 months
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.
Measured: 1 year
Predictive factors of CPAP adherence at three-months
Compliance data on CPAP use will be automatically collected by CPAP telemonitoring
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start7 Jun 2021
- Primary completion30 Jan 2024
- Study completion28 Feb 2024
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, open, multicentric, national and uncontrolled study.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- SEFAM MEDICAL (Villiers les Nancy, France)
- Responsible party
- Sponsor
- Investigators
- Jean-Louis JLP Pépin, PhD, Principal investigator, University Hospital, GrenobleDany DJ Jaffuel, MD, Principal investigator, University Hospital, MontpellierThibaut TG Gentina, MD, Principal investigator, Clinique de la Louvière SELARL SPIRAL, LilleFrédéric FG Gagnadoux, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054180
- Sponsor's protocol ID
- 38RC18.338
- Acronym
- SLEEPCONNECT
- Status last verified
- Mar 2024
- First submitted
- 29 Jul 2019
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.
PubMed 27188535Malhotra A, Orr JE, Owens RL. On the cutting edge of obstructive sleep apnoea: where next? Lancet Respir Med. 2015 May;3(5):397-403. doi: 10.1016/S2213-2600(15)00051-X. Epub 2015 Apr 14.
PubMed 25887980Arnaud 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.
PubMed 19404644Aron-Wisnewsky J, Clement K, Pepin JL. Nonalcoholic fatty liver disease and obstructive sleep apnea. Metabolism. 2016 Aug;65(8):1124-35. doi: 10.1016/j.metabol.2016.05.004. Epub 2016 May 13.
PubMed 27324067McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.
PubMed 27571048Jullian-Desayes I, Joyeux-Faure M, Tamisier R, Launois S, Borel AL, Levy P, Pepin JL. Impact of obstructive sleep apnea treatment by continuous positive airway pressure on cardiometabolic biomarkers: a systematic review from sham CPAP randomized controlled trials. Sleep Med Rev. 2015 Jun;21:23-38. doi: 10.1016/j.smrv.2014.07.004. Epub 2014 Jul 31.
PubMed 25220580Craig SE, Kohler M, Nicoll D, Bratton DJ, Nunn A, Davies R, Stradling J. Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Thorax. 2012 Dec;67(12):1090-6. doi: 10.1136/thoraxjnl-2012-202178. Epub 2012 Oct 30.
PubMed 23111478Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.
PubMed 20522795Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187.
PubMed 24918371Schwab RJ, Badr SM, Epstein LJ, Gay PC, Gozal D, Kohler M, Levy P, Malhotra A, Phillips BA, Rosen IM, Strohl KP, Strollo PJ, Weaver EM, Weaver TE; ATS Subcommittee on CPAP Adherence Tracking Systems. An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. Am J Respir Crit Care Med. 2013 Sep 1;188(5):613-20. doi: 10.1164/rccm.201307-1282ST.
PubMed 23992588Redline S, Dean D 3rd, Sanders MH. Entering the era of "big data": getting our metrics right. Sleep. 2013 Apr 1;36(4):465-9. doi: 10.5665/sleep.2524. No abstract available.
PubMed 23564993Hwang D. Monitoring Progress and Adherence with Positive Airway Pressure Therapy for Obstructive Sleep Apnea: The Roles of Telemedicine and Mobile Health Applications. Sleep Med Clin. 2016 Jun;11(2):161-71. doi: 10.1016/j.jsmc.2016.01.008. Epub 2016 Mar 26.
PubMed 27236054Coiffier O, Bailly S, Joyeux-Faure M, Tamisier R, Amrani K, Cornu JC, Gentina T, Terrail R, Causse C, Lombardi C, Pengo MF, Parati G, Pepin JL. Home Blood Pressure Trajectories during 6 Months of Continuous Positive Airway Pressure Therapy: Results from the eMEUSE-SANTE and SLEEPCONNECT Clinical Trials. Ann Am Thorac Soc. 2026 Jan 1;23(1):117-124. doi: 10.1513/AnnalsATS.202505-504OC.
PubMed 40986800
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)
- ClinicalTrials.gov ID
- NCT04054180
- Acronym / sponsor ID
- SLEEPCONNECT / 38RC18.338
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Continuous positive airway pressure, Connected devices
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- SEFAM MEDICAL (Villiers les Nancy, France)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 13 Aug 2019 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, open, multicentric, national and uncontrolled study.
| Arm | Type | Receives |
|---|---|---|
| CPAP S.Box associated with its 3 connected devices | Experimental | Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitorS.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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| CPAP associated with connected devices: blood pressure monitor , scales and activity monitorCPAP 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. | Other | CPAP S.Box associated with its 3 connected devices |
Primary outcome
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.
15 secondary outcomes
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
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
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
Comparison of number of steps measured before initiating CPAP and at 3 months
Time frame: baseline and 3 months
Evaluation of change in biological laboratory parameters
Time frame: baseline and 3 months
Evaluation of change in biological laboratory parameters
Time frame: baseline and 3 months
Weight variation over three months
Time frame: 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
Comparison of residual AHI between Polylink respiratory polygraphic data and AHI measurement by CPAP S.Box
Time frame: 24 hours
Analysis of responses to a specific usability questionnaire
Time frame: 3 months
Epworth sleepiness scale (ESS)
Time frame: baseline and 3 months
Pichot fatigue scale (PWS)
Time frame: baseline and 3 months
Assessment of health-related quality of life using the EQ-5D questionnaire
Time frame: baseline and 3 months
Analysis of all primary and secondary outcome measures at 1 year
Time frame: 1 year
Predictive factors of CPAP adherence at three-months
Time frame: 3 months
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 27188535Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.
- Background: PubMed 25887980Malhotra A, Orr JE, Owens RL. On the cutting edge of obstructive sleep apnoea: where next? Lancet Respir Med. 2015 May;3(5):397-403. doi: 10.1016/S2213-2600(15)00051-X. Epub 2015 Apr 14.
- Background: PubMed 19404644Arnaud 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.
- Background: PubMed 27324067Aron-Wisnewsky J, Clement K, Pepin JL. Nonalcoholic fatty liver disease and obstructive sleep apnea. Metabolism. 2016 Aug;65(8):1124-35. doi: 10.1016/j.metabol.2016.05.004. Epub 2016 May 13.
- Background: PubMed 27571048McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.
- Background: PubMed 25220580Jullian-Desayes I, Joyeux-Faure M, Tamisier R, Launois S, Borel AL, Levy P, Pepin JL. Impact of obstructive sleep apnea treatment by continuous positive airway pressure on cardiometabolic biomarkers: a systematic review from sham CPAP randomized controlled trials. Sleep Med Rev. 2015 Jun;21:23-38. doi: 10.1016/j.smrv.2014.07.004. Epub 2014 Jul 31.
- Background: PubMed 23111478Craig SE, Kohler M, Nicoll D, Bratton DJ, Nunn A, Davies R, Stradling J. Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Thorax. 2012 Dec;67(12):1090-6. doi: 10.1136/thoraxjnl-2012-202178. Epub 2012 Oct 30.
- Background: PubMed 20522795Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.
- Background: PubMed 24918371Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187.
- Background: PubMed 23992588Schwab RJ, Badr SM, Epstein LJ, Gay PC, Gozal D, Kohler M, Levy P, Malhotra A, Phillips BA, Rosen IM, Strohl KP, Strollo PJ, Weaver EM, Weaver TE; ATS Subcommittee on CPAP Adherence Tracking Systems. An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. Am J Respir Crit Care Med. 2013 Sep 1;188(5):613-20. doi: 10.1164/rccm.201307-1282ST.
- Background: PubMed 23564993Redline S, Dean D 3rd, Sanders MH. Entering the era of "big data": getting our metrics right. Sleep. 2013 Apr 1;36(4):465-9. doi: 10.5665/sleep.2524. No abstract available.
- Background: PubMed 27236054Hwang D. Monitoring Progress and Adherence with Positive Airway Pressure Therapy for Obstructive Sleep Apnea: The Roles of Telemedicine and Mobile Health Applications. Sleep Med Clin. 2016 Jun;11(2):161-71. doi: 10.1016/j.jsmc.2016.01.008. Epub 2016 Mar 26.
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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.
Jean-Louis JLP Pépin, PhD principal investigator
University Hospital, Grenoble
Dany DJ Jaffuel, MD principal investigator
University Hospital, Montpellier
Thibaut TG Gentina, MD principal investigator
Clinique de la Louvière SELARL SPIRAL, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP associated with connected devices: blood pressure monitor , scales and activity monitor in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mean value of 18 self measures blood pressure (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04054180, which also lists 13 linked publications.
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 6 Mar 2024.