Impact of Telemonitoring to Improve Adherence in Continuous Positive Airway Pressure (CPAP)-Treated Patients

• ClinicalTrials.gov Identifier: NCT02773953
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Last Update Posted: April 26, 2017
• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Information provided by (Responsible Party): Centre Hospitalier Universitaire Saint Pierre

Study Description

Brief Summary:

Improvement in CPAP adherence can be obtained by usingTelemonitoring. T4P® is a telemonitoring unit added on CPAP device allowing to obtain a daily report of usage duration, mask leaks, pressure and apnea-hypopnea index. The purpose of this study is to assess the impact of telemonitoring on the delay to the first technical intervention after CPAP titration night in CPAP-treated obstructive sleep apnea patients managed in the sleep unit. The shortening of this delay could help to improve adherence during the first weeks of treatment. As a secondary aim, the investigators would like to assess the impact of telemonitoring on mean adherence during the first 3 months of treatment, which is a crucial period.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Device: T4PTelemonitoring; Device: CPAP	Not Applicable

Detailed Description:

Introduction CPAP (continuous positive airway pressure) is the most frequently used and effective treatment for obstructive sleep apnea syndrome (OSAS).

It has been proven to offer a survival benefit in patients with severe disease, to improve sleep quality, health-related quality of life and to decrease cardiovascular events, such as stroke and myocardial infarction.

The challenge of this treatment remains to obtain adequate adherence, defined as use during at least 4 hours/night and for more than 70% of the nights . Independently of this usually accepted cut-off, CPAP effect grows with increased use. A recent randomised study in a cohort of 3100 CPAP-treated patients, randomised in intensive versus standard interventions, has also confirmed the positive effect of a greater CPAP use (6.9 vs 5.2 h/night) on cardiovascular outcomes, indicating that a regular 5-6 hours use/night is required.

Improvement in adherence can be obtained by supportive, educational and behavioural therapy . CPAP specific education is nowadays routinely applied in the center.

Telemonitoring has also been shown to improve adherence. Other studies have added telemonitoring vs. placebo to the usual care in 45 recently diagnosed OSA patients and observed a 46% adherence improvement in the telemonitoring group after 2 months.

In another randomised trial, daily download of CPAP data and consecutive phone-call intervention to usual care in 75 OSAS patients. After 3 months, mean adherence was 321 min in the telemonitoring arm versus 207 min in the standard arm during the days of use.

T4P® is a telemonitoring unit added on CPAP device allowing to obtain a daily report of usage duration, mask leaks, pressure and apnea-hypopnea index. Data are anonymously transmitted to a secured server and analysed on a dedicated web portal.

The purpose of the present study is to assess the impact of telemonitoring on the delay to the first technical intervention after CPAP titration night in CPAP-treated OSAS patients managed in the sleep unit. The shortening of this delay could help to improve adherence during the first weeks of treatment. As secondary aim, investigators would like to assess the impact of telemonitoring on mean adherence during the first 3 months of treatment, which is a crucial period.

Material and methods Consecutive OSAS patients admitted in the sleep unit for CPAP titration night will be screened. If patients accept to participate to the study, they will be randomised between standard care or telemonitoring CPAP follow-up.

Standard care After CPAP titration night, patients are instructed to use the device each night for the whole night. They receive written instruction and can reach the sleep unit (phone call, visit) how often they need, during week days, in order to resolve any intercurrent problem interfering with their CPAP use. A group educational session for CPAP-treated patients is scheduled 1 month after and a visit to the pneumologist is scheduled 1.5 months after.

Telemonitoring follow-up In addition to standard care, the T4P® is added to the CPAP of the patient at home. Sleep lab technical staff is instructed to connect to the web portal and to analyse patient's data each Tuesdays and Fridays. In case of air leaks, persistant significant apnea-hypopnea index, use < 3h on three consecutive days, investigators have to call the patient and eventually to ask him to visit the staff of the sleep lab.

Outcomes

• delay between CPAP titration night and first intervention (phone call/visit)
• mean CPAP adherence measured during the first 3 months of treatment

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Telemonitoring on Delay of Intervention to Improve Precocious Adherence in CPAP-treated Sleep Apnea Patients
• Study Start Date: April 2016
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: March 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: CPAP + T4PTelemonitoring device; T4P® (Telemonitoring device) is added to CPAP at home. Sleep lab technical staff are connecting to the web portal 2 X/ week. In case of air leaks, persistant significant apnea-hypopnea index, use < 3h on three consecutive days, they have to call the patient .	Device: T4PTelemonitoring; addition of a Telemonitoring unit on the CPAP line to standard care.; Device: CPAP; CPAP treatment for treatment of obstructive sleep apnea syndrome
Active Comparator: CPAP standard care; After CPAP titration night, patients are instructed to use the device each night for the whole night. They receive written instruction and can reach the sleep unit (phone call, visit) how often they need, during week days, to resolve CPAP-related problems. A group educational session is scheduled 1 month after and a visit to the pneumologist 1.5 months after.	Device: CPAP; CPAP treatment for treatment of obstructive sleep apnea syndrome

Outcome Measures

Primary Outcome Measures :

1. Intervention delay (days) [ Time Frame: 3 months ]
   Delay between CPAP titration night and first intervention (phone call/visit)

Secondary Outcome Measures :

1. Adherence to treatment [ Time Frame: 3 months ]
   daily use of CPAP (h/day)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with obstructive sleep apnea syndrome and AHI > 20/h, who start treatment with CPAP.

Exclusion Criteria:

• Patients already on treatment with CPAP.
• Patients leaving Belgium for more than 3 weeks during study period.
• Severe restrictive respiratory disorders.
• Severe respiratory or cardiac disease.
• Severe psychiatric disease.

Contacts and Locations

Locations

Belgium

CHU st Pierre-sleep lab

Brussels, Belgium, 1000

Sponsors and Collaborators

Centre Hospitalier Universitaire Saint Pierre

Investigators

• Principal Investigator: Marie Bruyneel, MD, Phd; CHU St. Pierre, Brussels

More Information

• Responsible Party: Centre Hospitalier Universitaire Saint Pierre
• ClinicalTrials.gov Identifier: NCT02773953
• Other Study ID Numbers: AK/16-03-39/4634
• First Posted: May 16, 2016
• Last Update Posted: April 26, 2017
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire Saint Pierre:

CPAP; Telemonitoring

Additional relevant MeSH terms:

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