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

NCT04054180 | Terminated

• 1 other identifier: 38RC18.338
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Continuous positive airway pressure; Connected devices

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  baseline to 3 months

• Comparison of variability of 18 measurements of DBP by self-measurement, between inclusion and after 3 months of CPAP treatment

  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

  baseline to 3 months

• Comparison of number of steps measured before initiating CPAP and at 3 months

  baseline and 3 months

• Evaluation of change in biological laboratory parameters

  baseline and 3 months

Study Arms (1)

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.

Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor

Interventions

CPAP associated with connected devices: blood pressure monitor , scales and activity monitor OTHER

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.

CPAP S.Box associated with its 3 connected devices

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• SEFAM MEDICAL (Villiers les Nancy, France): collaborator

Study Sites (1)

UniversityHospitalGrenoble

Grenoble, 38043, France

Location

Related Publications (13)

• 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.

  PMID: 27188535 BACKGROUND

• Malhotra 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.

  PMID: 25887980 BACKGROUND

• 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.

  PMID: 19404644 BACKGROUND

• Aron-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.

  PMID: 27324067 BACKGROUND

• McEvoy 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.

  PMID: 27571048 BACKGROUND

• Jullian-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.

  PMID: 25220580 BACKGROUND

• Craig 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.

  PMID: 23111478 BACKGROUND

• Pepin 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.

  PMID: 20522795 BACKGROUND

• Chirinos 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.

  PMID: 24918371 BACKGROUND

• Schwab 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.

  PMID: 23992588 BACKGROUND

• Redline 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.

  PMID: 23564993 BACKGROUND

• Hwang 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.

  PMID: 27236054 BACKGROUND

• Coiffier 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 Clinic. Ann Am Thorac Soc. 2025 Sep 23. doi: 10.1513/AnnalsATS.202505-504OC. Online ahead of print.

  PMID: 40986800 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Weights and Measures; Fitness Trackers

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, open, multicentric, national and uncontrolled study.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 13, 2019
• Study Start: June 7, 2021
• Primary Completion: January 30, 2024
• Study Completion: February 28, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

FR (1)