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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
T4PTelemonitoring
CPAP
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring CPAP, Telemonitoring

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU st Pierre-sleep lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPAP + T4PTelemonitoring device

CPAP standard care

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

Intervention delay (days)
Delay between CPAP titration night and first intervention (phone call/visit)

Secondary Outcome Measures

Adherence to treatment
daily use of CPAP (h/day)

Full Information

First Posted
April 25, 2016
Last Updated
April 25, 2017
Sponsor
Centre Hospitalier Universitaire Saint Pierre
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1. Study Identification

Unique Protocol Identification Number
NCT02773953
Brief Title
Impact of Telemonitoring to Improve Adherence in Continuous Positive Airway Pressure (CPAP)-Treated Patients
Official Title
Impact of Telemonitoring on Delay of Intervention to Improve Precocious Adherence in CPAP-treated Sleep Apnea Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
CPAP, Telemonitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP + T4PTelemonitoring device
Arm Type
Experimental
Arm Description
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 .
Arm Title
CPAP standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
T4PTelemonitoring
Intervention Description
addition of a Telemonitoring unit on the CPAP line to standard care.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP treatment for treatment of obstructive sleep apnea syndrome
Primary Outcome Measure Information:
Title
Intervention delay (days)
Description
Delay between CPAP titration night and first intervention (phone call/visit)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adherence to treatment
Description
daily use of CPAP (h/day)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bruyneel, MD, Phd
Organizational Affiliation
CHU St. Pierre, Brussels
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU st Pierre-sleep lab
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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