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

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 |

Arm | Intervention/treatment |
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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 .
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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.
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Device: CPAP
CPAP treatment for treatment of obstructive sleep apnea syndrome |
- Intervention delay (days) [ Time Frame: 3 months ]Delay between CPAP titration night and first intervention (phone call/visit)
- 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 |
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.

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
Belgium | |
CHU st Pierre-sleep lab | |
Brussels, Belgium, 1000 |
Principal Investigator: | Marie Bruyneel, MD, Phd | CHU St. Pierre, Brussels |
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 |
CPAP Telemonitoring |
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |