Clinical trial NCT03043716: Long-term Observation of PAP-therapy With Telemonitoring: Telemedicine Registry TelePAP
Official title: Long-term Observation of Adherence and Efficacy of Patients With a Positive Airway Pressure (PAP) Therapy With Use of Telemonitoring
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obstructive Sleep Apnea
Central Sleep Apnea
Mixed Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: RWTH Aachen University
First posted: 2017-02-06
Enrollment: 14147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals with an indication for a therapy with positive airway pressure. Sleep breathing disorders can be obstructive (obstructive sleep apnea, OSA) or central (CSA) ranging from mild forms (apnoea-hypopnoea-index ˃ 5 and ˂ 15) over moderate (AHI ˃15 and ˂30) or severe (AHI ˃ 30).

Brief summary: Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy on long-term outcomes.

Detailed description: Airway obstructions, airflow resistance by partial occlusion of the airways or central sleep-breathing disorders, where the respiratory effort is reduced or stops, cause a reduction in airflow and lead to arousals from sleep and disturbances in gas exchange during sleep. The negative consequences manifest in increases of blood pressure, higher workload for the heart and daytime sleepiness. PAP (positive airway pressure) treats sleep-related breathing disorders. It applies pressure to nose and mouth to keep the airway from collapsing and provides pressure support to assist the respiratory muscles. The efficacy of the therapy is measured with apnoea- and hypopnoea-indices that count the total number of apnoeic events at night. To ensure an efficacious and efficient therapy, pressures have to be adjusted correctly and the patient needs to use PAP regularly.

Telemonitoring is information and communication technology to exchange sleep data and to provide clinical guidance over distances. There is no defined spectrum of technology. It can comprise phone calls, video support or interaction programs via the internet. Some studies point to advantages of telemonitoring in keeping compliance upright, increase usage hours and some also point to economic advantages. However, we do not have conclusive data from large trials with telemonitoring on the long-term that would show conclusive effects, be it from the side of a patient or from a cost and labour perspective of providers or the healthcare sector. Still, there are uncertainties regarding data safety, reimbursement or connectivity of different systems.

No long-term data of PAP therapy under telemonitoring and its effect on compliance and therapy outcomes is available by now.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* New indication for a prescription of a Telemonitoring (AirViewTM)-capable ResMed PAP-device
* Consent to use the telemonitoring System AirViewTM (ResMed GmbH \& Co KG)
* Signed Informed Consent

Exclusion Criteria:

- Pregnant and breastfeeding persons

Primary outcomes:
measure: Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring
timeFrame: 24 months
Secondary outcomes:
measure: Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up
timeFrame: 24 months
measure: Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up
timeFrame: 24 months
measure: Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) comparing the score at baseline with the 24 months follow-up
timeFrame: 24 months
measure: Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up
timeFrame: 24 months
Other outcomes:
Locations:
city: Blaubeuren
country: Germany
facility: Schlaf- und Beatmungszentrum Blaubeuren
state: Baden-Württemberg
city: Fürth
country: Germany
facility: Ambulante Schlafmedizin Herold/Kaa
state: Bavaria
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg-Med Klinik 3
state: Bavaria
city: Dusseldorf
country: Germany
facility: Klinik für Schlafmedizin Düsseldorf Grand Arc
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
state: Northrhine-Westphalia
city: Berlin
country: Germany
facility: Zentrum für Schlafmedizin Dr. Warmuth
Study officials:
affiliation: Grand Arc Düsseldorf
name: Hartmut Grüger, Dr
role: PRINCIPAL_INVESTIGATOR
References: