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

Obstructive Sleep Apnea Syndrome Clinical Trial

— SLEEPCONNECT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04054180
• Other study ID #: 38RC18.338
• Status: Terminated
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: February 28, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	SEFAM MEDICAL (Villiers les Nancy, France)

Country where clinical trial is conducted

France, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline to 3 months
Secondary	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.	baseline to 3 months
Secondary	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.	baseline to 3 months
Secondary	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.	baseline and 3 months
Secondary	Evaluation of change in biological laboratory parameters	Comparison of fasting glucose between baseline and after 3 months of CPAP treatment	baseline and 3 months
Secondary	Evaluation of change in biological laboratory parameters	Comparison of lipid profile between baseline and after 3 months of CPAP treatment	baseline and 3 months
Secondary	Weight variation over three months	Weight will be recorded using their connected devices at baseline, and 3 months of CPAP treatment.	baseline and 3 months
Secondary	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.	baseline
Secondary	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	24 hours
Secondary	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?	3 months
Secondary	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.	baseline and 3 months
Secondary	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.	baseline and 3 months
Secondary	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	baseline and 3 months
Secondary	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.	1 year
Secondary	Predictive factors of CPAP adherence at three-months	Compliance data on CPAP use will be automatically collected by CPAP telemonitoring	3 months