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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




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)



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773953


Locations
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Belgium
CHU st Pierre-sleep lab
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Principal Investigator: Marie Bruyneel, MD, Phd CHU St. Pierre, Brussels
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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    Key Record Dates
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:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases