Obstructive Sleep ApneaTelePAPNCT03043716
Long-term Observation of PAP-therapy With Telemonitoring: Telemedicine Registry TelePAP
An observational study of Obstructive Sleep Apnea and Central Sleep Apnea, run by ResMed at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea
- What is being tested?
- PAP therapy with telemonitoring
- How many people
- 14,147 participants
- Where
- 6 sitesGermany
- Study dates
- 1 Aug 2017to 31 Jul 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Pregnant and breastfeeding persons
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Zentrum für Schlafmedizin Dr. Warmuth
Berlin, State of Berlin, 12683
Schlaf- und Beatmungszentrum Blaubeuren
Blaubeuren Abbey, Baden-Wurttemberg, 89143
Klinik für Schlafmedizin Düsseldorf Grand Arc
Düsseldorf, North Rhine-Westphalia, 40235
Ruhrlandklinik Essen
Essen, North Rhine-Westphalia, 45239
Ambulante Schlafmedizin Herold/Kaa
Fürth, Bavaria, 90762
Klinikum Nürnberg-Med Klinik 3
Nuremberg, Bavaria, 90419
About this study
Official title: Long-term Observation of Adherence and Efficacy of Patients With a Positive Airway Pressure (PAP) Therapy With Use of Telemonitoring
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.
Read the 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.
- Being tested
- PAP therapy with telemonitoring
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea, Central, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAP therapy with telemonitoringOther
Patients will receive a prescription for PAP therapy in the course of their clinical Routine pathway and afterwards be asked to enrol in the registry. The will be asked if they are willing to use telemonitoring technology.
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring
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)
Measured: 24 months
Secondary outcomes (4)
Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up
Sleep disorders are snoring, insomnia, hypersomnia, depression, restless legs syndrome as assessed by anamnesis.
Measured: 24 months
Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up
Efficacy is measured through changes in Apnea-Hypopnea-Index AHI (numbers of apneas - reduction of airflow by >90% for at least 10 seconds - and hypopneas - reduction of airflow by >30% for at least 10 seconds with a 4% decrease of Oxygen Saturation - divided by hours of sleep), AI - apnea index (apneas per hour), HI hypopnea index (hypopneas per hour).
Measured: 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
The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life.
Measured: 24 months
Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up
Possible causes for therapy Termination are assessed: Lost-to-follow-up, no interest in therapy, changed physician, no therapy benefits, Hospital stay, death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start1 Aug 2017
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,147 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RWTH Aachen University
- Responsible party
- Sponsor
- Investigators
- Hartmut Grüger, Dr, Principal investigator, Grand Arc Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043716
- Sponsor's protocol ID
- TelePAP_Protokoll_V02_17072017
- Acronym
- TelePAP
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2017
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observation of Adherence and Efficacy of Patients With a Positive Airway Pressure (PAP) Therapy With Use of Telemonitoring
- ClinicalTrials.gov ID
- NCT03043716
- Acronym / sponsor ID
- TelePAP / TelePAP_Protokoll_V02_17072017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,147 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- RWTH Aachen University
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant and breastfeeding persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAP therapy with telemonitoringPatients will receive a prescription for PAP therapy in the course of their clinical Routine pathway and afterwards be asked to enrol in the registry. The will be asked if they are willing to use telemonitoring technology. | Other | – |
Primary outcome
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)
4 secondary outcomes
Sleep disorders, assessed by personally questioning the Patient at baseline and at 24 months follow-up
Time frame: 24 months
Therapy efficacy, assessed through changes in AHI and HI comparing baseline with 24 months follow-up
Time frame: 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
Time frame: 24 months
Factors leading to therapy Termination, assessed by personally questioning a Patient or Consulting a physician at time of follow-up
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hartmut Grüger, Dr principal investigator
Grand Arc Düsseldorf
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Central Sleep Apnea, run by ResMed at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage Patterns of PAP therapy with telemonitoring, assessed by data continuously recorded by the device and transferred via telemonitoring (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.