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

NCT02773953 | Completed

• 1 other identifier: AK/16-03-39/4634
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

CPAP; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• Intervention delay (days)

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

  3 months

Secondary Outcomes (1)

• Adherence to treatment

  3 months

Study Arms (2)

CPAP + T4PTelemonitoring device

EXPERIMENTAL

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; Device: CPAP

CPAP standard care

ACTIVE COMPARATOR

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

Interventions

T4PTelemonitoring DEVICE

addition of a Telemonitoring unit on the CPAP line to standard care.

CPAP + T4PTelemonitoring device

CPAP DEVICE

CPAP treatment for treatment of obstructive sleep apnea syndrome

CPAP + T4PTelemonitoring device; CPAP standard care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU st Pierre-sleep lab

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie Bruyneel, MD, Phd

  CHU St. Pierre, Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 16, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)