Long-term Observation of Adherence and Efficacy of Patients With a Positive Airway Pressure (PAP) Therapy With Use of Telemonitoring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- ResMed
- Enrollment
- 14147
- Locations
- 6
- Primary Endpoint
- Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring
Time Frame: 24 months
Usage Patterns are hours/night and nights/month that therapy has been used. Telemonitoring enables the physician to remotely supervise device usage. Usage will be assessed through data recordings of the device: Days of usage \>3hours; Days of usage \<3 hours; total recorded days; mean daily usage (minutes); total usage hours (h)
Secondary Outcomes
- Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up(24 months)
- Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up(24 months)
- Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) comparing the score at baseline with the 24 months follow-up(24 months)
- Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up(24 months)