AherenceCPAP OSANCT06520592
The Effectiveness of Augmented Reality to Enhance CPAP Therapy in OSA Patients
A study testing With AR guided CPAP therapy in people with Aherence and Physical Symptoms, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aherence, Physical Symptoms, Mental Health
- What is being tested?
- With AR guided CPAP therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) Diagnosed with moderate to severe obstructive sleep apnea (AHI≥15) through polysomnography (PSG).
- (2) Age is equal to or greater than 20 years old or equal.
Who cannot join
- (1) individuals who have previously used positive pressure ventilators for treatment,
- (2) those diagnosed with central sleep apnea,
- (3) those with uncontrolled acute mental illness,
- (4) terminally ill patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Using Augmented Reality to Establish and Evaluate the Effectiveness of a Set of Continuous Positive Airway Pressure Care Management Protocol for Obstructive Sleep Apnea Patients
The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. The main questions it aims to answer are:
Does AR guided CPAP therapy increase the adherence of CPAP therapy among OSA patients? What barriers do participants have when using AR guided CPAP therapy? Researchers will compare AR guided CPAP therapy to a control (standard of care) to see if AR guided CPAP therapy works to enhance the adherence of CPAP therapy.
Read more
Participants will:
- Take AR guided CPAP therapy or standard of care every day for 6 months
- Visit the clinic on baseline (t0), receiving CPAP therapy at the 1st month (t1), for checkups and tests, receiving CPAP therapy at the 3rd month (t2), receiving CPAP therapy at the 6th month (t3).
- Response their symptoms on each following time.
Read the detailed description
Participants will randomly assign to two group, for experimental group will be received AR guided CPAP therapy. In the control group will be received standard of care.
- Conditions
- Aherence, Physical Symptoms, Mental Health, Quality of Life
- Being tested
- With AR guided CPAP therapy
- Keywords
- Augmented Reality (AR), continuous positive airway pressure (CPAP), Adherence, Symptoms change
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With AR guided CPAP therapyBehavioural
Participants will received AR training course to utilize the AR guided CPAP therapy
| Study group | Role | What they receive |
|---|---|---|
| With AR guided CPAP therapy | Experimental | OSA patientns were assigned to experimental group, they will be received AR guided CPAP therapy Receives: Behavioral: With AR guided CPAP therapy |
| Standard of care | No intervention | OSA patientns were assigned to stand of care group, they will be not received AR guided CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adherence of CPAP therapy
Adherence refers to the patient's adherence to CPAP therapy, which means using CPAP for more than 70% of the total sleep time during the night, with a minimum duration of 4 hours. The calculation method involves dividing the number of days with CPAP use exceeding 4 hours by the total number of days and multiplying by 100 to obtain the average percentage of CPAP usage.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start24 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AherenceStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the interventional group, they will utilize AR-guided CPAP therapy to ensure a proper fit of the CPAP device mask and successful adherence to the CPAP therapy. For the standard of care group, they will receive the standard of care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen, Yen-Chin, National Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520592
- Sponsor's protocol ID
- A-ER-111-531
- Other IDs
- 112-2628-B-110 -006 -MY3
- Acronym
- CPAP OSA
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0.
PubMed 27542595Bakker JP, Weaver TE, Parthasarathy S, Aloia MS. Adherence to CPAP: What Should We Be Aiming For, and How Can We Get There? Chest. 2019 Jun;155(6):1272-1287. doi: 10.1016/j.chest.2019.01.012. Epub 2019 Jan 23.
PubMed 30684472Wiederhold BK. How Virtual Reality Is Changing the Reality of Aging. Cyberpsychol Behav Soc Netw. 2020 Mar;23(3):141-142. doi: 10.1089/cyber.2020.29176.bkw. No abstract available.
PubMed 32150700Chen YC, Frange C, Pan SS, Ng CM, Chen YH, Lin CY. Beyond the Mask-Psychological Discomfort as a Predictor of Early CPAP Nonadherence in Moderate-to-Severe OSA Patients: A Prospective Mixed-Methods Study. Nurs Res Pract. 2026 Apr 6;2026:9630236. doi: 10.1155/nrp/9630236. eCollection 2026.
PubMed 41953147Chen MC, Chen YC, Lin CY. Enhancing Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Using Augmented Reality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 6;14:e69757. doi: 10.2196/69757.
PubMed 40327384
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Augmented Reality to Establish and Evaluate the Effectiveness of a Set of Continuous Positive Airway Pressure Care Management Protocol for Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT06520592
- Acronym / sponsor ID
- CPAP OSA / A-ER-111-531
- Conditions
- Aherence, Physical Symptoms, Mental Health, Quality of Life
- Keywords
- Augmented Reality (AR), continuous positive airway pressure (CPAP), Adherence, Symptoms change
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- 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.
The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. The main questions it aims to answer are:
Does AR guided CPAP therapy increase the adherence of CPAP therapy among OSA patients? What barriers do participants have when using AR guided CPAP therapy? Researchers will compare AR guided CPAP therapy to a control (standard of care) to see if AR guided CPAP therapy works to enhance the adherence of CPAP therapy.
Participants will:
- Take AR guided CPAP therapy or standard of care every day for 6 months
- Visit the clinic on baseline (t0), receiving CPAP therapy at the 1st month (t1), for checkups and tests, receiving CPAP therapy at the 3rd month (t2), receiving CPAP therapy at the 6th month (t3).
- Response their symptoms on each following time.
Detailed description
Participants will randomly assign to two group, for experimental group will be received AR guided CPAP therapy. In the control group will be received standard of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- For the interventional group, they will utilize AR-guided CPAP therapy to ensure a proper fit of the CPAP device mask and successful adherence to the CPAP therapy. For the standard of care group, they will receive the standard of care.
| Arm | Type | Receives |
|---|---|---|
| With AR guided CPAP therapy | Experimental | Behavioral: With AR guided CPAP therapyOSA patientns were assigned to experimental group, they will be received AR guided CPAP therapy |
| Standard of care | No intervention | –OSA patientns were assigned to stand of care group, they will be not received AR guided CPAP therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- (1) Diagnosed with moderate to severe obstructive sleep apnea (AHI≥15) through polysomnography (PSG).
- (2) Age is equal to or greater than 20 years old or equal.
Key exclusion criteria (4 listed)
- (1) individuals who have previously used positive pressure ventilators for treatment,
- (2) those diagnosed with central sleep apnea,
- (3) those with uncontrolled acute mental illness,
- (4) terminally ill patients.
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 |
|---|---|---|
| With AR guided CPAP therapyParticipants will received AR training course to utilize the AR guided CPAP therapy | Behavioural | With AR guided CPAP therapy |
Primary outcome
The adherence of CPAP therapy
Time frame: From enrollment to the end of treatment at 6 months
Adherence refers to the patient's adherence to CPAP therapy, which means using CPAP for more than 70% of the total sleep time during the night, with a minimum duration of 4 hours. The calculation method involves dividing the number of days with CPAP use exceeding 4 hours by the total number of days and multiplying by 100 to obtain the average percentage of CPAP usage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Results publication: PubMed 27542595Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0.
- Results publication: PubMed 30684472Bakker JP, Weaver TE, Parthasarathy S, Aloia MS. Adherence to CPAP: What Should We Be Aiming For, and How Can We Get There? Chest. 2019 Jun;155(6):1272-1287. doi: 10.1016/j.chest.2019.01.012. Epub 2019 Jan 23.
- Results publication: PubMed 32150700Wiederhold BK. How Virtual Reality Is Changing the Reality of Aging. Cyberpsychol Behav Soc Netw. 2020 Mar;23(3):141-142. doi: 10.1089/cyber.2020.29176.bkw. No abstract available.
- Derived from this study: PubMed 41953147Chen YC, Frange C, Pan SS, Ng CM, Chen YH, Lin CY. Beyond the Mask-Psychological Discomfort as a Predictor of Early CPAP Nonadherence in Moderate-to-Severe OSA Patients: A Prospective Mixed-Methods Study. Nurs Res Pract. 2026 Apr 6;2026:9630236. doi: 10.1155/nrp/9630236. eCollection 2026.
- Derived from this study: PubMed 40327384Chen MC, Chen YC, Lin CY. Enhancing Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Using Augmented Reality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 6;14:e69757. doi: 10.2196/69757.
- Individual participant dataSharing planned: No
Related trials for Aherence
Recruiting
Adherence to Different Exercise Interventions
Exercise Adherence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With AR guided CPAP therapy in people with Aherence and Physical Symptoms, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
The adherence of CPAP therapy (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06520592, which also lists 5 linked publications.
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 15 Oct 2026.