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

April 25, 2017 updated by: Centre Hospitalier Universitaire Saint Pierre

Impact of Telemonitoring on Delay of Intervention to Improve Precocious Adherence in CPAP-treated Sleep Apnea Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • CHU st Pierre-sleep lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention delay (days)
Time Frame: 3 months
Delay between CPAP titration night and first intervention (phone call/visit)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: 3 months
daily use of CPAP (h/day)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK/16-03-39/4634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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