Efficacy of Wearable Device to Promote CPAP Adherence in Patients With Obstructive Sleep Apnea (OSA); A Randomized Controlled Trial
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Sponsor: Ramathibodi Hospital

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Reviewed by a human subject’s protection review board, Version 1, 2025-12-26 
Clinical Trial Protocol  
Based on STANDARD PROTOCOL ITEMS: RECOMMENDATIONS FOR INTERVENTIONAL TRIALS (SPIRIT) 2025 checklist 
(https://doi.org/10.1016/ S0140-6736(25)00770-6) 
Study Title (English):  Efficacy of wearable device to promote CPAP adherence in patients with 
obstructive sleep apnea (OSA); A randomized controlled trial 
Principal 
investigator:  
Visasiri Tantrakul 
Ramathibodi hospital, Mahidol university 
E-mail: Vtantrakul@gmail.com 
Tel: (66) 86-379-3629 
Co-investigator(s):  
 
1 Somruetai Matupumanon 
Ramathibodi hospital, Mahidol university 
E-mail: many_toon@hotmail.com 
Tel: (66) 86-379-3629 
2 Somprasong Liamsombut 
Ramathibodi hospital, Mahidol university 
E-mail: somprasong.l@hotmail.com 
Tel: (66) 81-804-5702 
3 Pongsakorn Tanayapong 
Ramathibodi hospital, Mahidol university 
E-mail: tnypongs@gmail.com 
Tel: (66) 64-962-6252 
4 Suparee Wisawapipat Boonmanunt 
Ramathibodi hospital, Mahidol university 

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Reviewed by a human subject’s protection review board, Version 1, 2025-12-26 
E-mail: suparee.boo@mahidol.edu 
Tel: (66) 22011269  
Sponsor or planned 
sponsor, grant, 
scholarship <if 
applicable>: 
From Ramathibodi hospital 
Conflict of Interest: 
 
No conflict of interest 
Study sites (list all as 
planned):  
Ramathibodi hospital, Bangkok, Thailand 
Background and 
Significance:  
 
     Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent 
episodes of apnea or hypopnea, causing oxygen desaturation or sleep arousal and 
leading to sleep fragmentation, insomnia and daytime sleepiness. Associated 
features for OSA are systemic hypertension, cardiovascular disease (coronary 
artery disease, atrial fibrillation, stroke and transient ischemic attack), cognitive 
dysfunction that may impact for health, mental well-being, quality of life, and 
driving safety. Diagnosis of OSA involves polysomnography or home sleep apnea 
testing. (1)  
     Treatment options for obstructive sleep apnea include continuous positive 
airway pressure (CPAP) therapy, oral appliances, and surgery. CPAP is the standard 
treatment for obstructive sleep apnea. Since this device can relieve sleep-related 
symptoms and improve quality of life. (2) 
     The importance of CPAP use is increasingly recognized because the adherence 
to CPAP therapy is important. Using a CPAP machine throughout each night 
provides the best clinical outcomes. This has attracted interest in several recent 
studies to study whether adequate CPAP use can reduce symptoms such as 
daytime drowsiness, neurological disorders, hypertension, and improve quality of 
life. A previous study examined the effect of CPAP duration on 5-year survival 
rates and found that using the machine for more than one hour per night 
significantly reduced mortality. It was also suggested that "even a short period of 
CPAP use is better than no use at all." (3) 

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     Furthermore, it has been found that various patient interventions can increase 
CPAP use, such as telephone monitoring, telemonitoring, and smartphone apps. 
With the general population increasingly focused on health, various technologies 
are being utilized to facilitate basic self-assessment of health, such as smart 
watches and health rings.  
     Past study, eHealth interventions for adults with OSA can improve adherence 
to CPAP in the initial months after the start of treatment, increasing the mean 
nightly duration of use by about half an hour. (4) In later study, adult patients 
with OSA were randomized into two groups, standard care with telemedicine 
versus standard care alone, their results were significantly greater in the 
telemedicine arm (191 min per day) versus the standard arm (105 min per day; 
mean difference = 87 min, 95% confidence interval (CI): 25-148 min, P = 0.006, 
unpaired t test) after 3-month. (5) 
     Nowadays, patients or the general public are paying more attention to their 
health, especially their sleep health. This has led to the use of smart watches to 
screen for abnormalities in daily life. Wearable devices are beginning to be used 
to help assess patient with sleep symptoms in comparison to the gold standard 
diagnosis tools such as polysomnography. However, there is limited evidence on 
the effectiveness of wearable devices in enhancing CPAP adherence, particularly 
in Thai population 
     In the present, wearable devices are many brands that can be sleep tracker. In 
past study, they evaluate a performance validation of wearable device compared 
to polysomnography, the conclusion was all devices can benefit from further 
improvement for multistate categorization. However, the devices with higher 
Cohen’s kappa coefficients, such as the Fitbit Sense (κ = 0.42), Fitbit Charge 5 (κ 
= 0.41), and Apple Watch Series 8 (κ = 0.53), could be effectively used to track 
prolonged and significant changes in sleep architecture and other devices are fair 
to moderate agreement with PSG such as Garmin vivosmart4 (κ = 0.2) (6)  
     This study explored the use of wearable devices to increase CPAP use in 
patients with obstructive sleep apnea. This allows patients to use CPAP for more 
hours and days, resulting in better sleep health and quality of life. It also provides 
patients with health information that can be used to set their own health goals 
for the future. We choose Garmin vivoactive 5 in this research because of the 
validation is fair level, price, and there has a service center in Thailand. 

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Objectives:  
Primary Objective:   
objectives 
Endpoints (estimand) 
To evaluate adherence for CPAP used 
with wearable device in OSA patients 
comparing with controlled group  
1 Usage time of CPAP (minutes per 
day) 
2 %Usage > 4 hr 
 
Secondary 
Objectives (if any): 
objectives 
Endpoints (estimand) 
1 To assess sleepiness and quality of 
sleep in patients            
2 To study a correlation between 
sleep data from wearing a wearable 
device and data downloaded from the 
CPAP device 
3 To obtain other health data from 
wearing the wearable device and 
compare the data between the 2 
groups 
1 Sleepiness and quality of sleep 
using questionnaire (ESS and PSQI) 
2 Compare sleep architecture data 
from CPAP download and wearable 
device: total sleep time, light sleep, 
deep sleep, REM 
3 Collect other data from wearable 
device such as heart rate, stress level, 
oxygen saturation, steps count, and 
sleep score 
Study 
design/methodology: 
 
Randomized controlled trial in single center 
Wearable device group: use Garmin vivoactive 5 with standard of care for CPAP 
used and patients can monitor health data by themselves through Connect 
application 
Control group: use Garmin vivoactive 5 with standard of care for CPAP used and 
patients don’t be allowed to use Connect application but they will be able to 
view limited on-screen information, such as average oxygen saturation, sleep 
score, and step count. The screen brightness will be adjusted to the lowest level 
to minimize light exposure during sleep. 
Randomized to either wearable device group or control group by block 
randomization with block size = 4 
 
 
 
 

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Study Population 
Patients with moderate to severe obstructive sleep apnea to be treat with CPAP 
therapy 
Inclusion Criteria: 
 
1 Adult patients (≥ 19 yr of age) with moderate to severe OSA (AHI ≥ 15 
events/hr by polysomnography (PSG), according to the American 
Patient is diagnosed with moderate to severe OSA (AHI > 15 events/hours)  
Inclusion criteria 
- Adult patients (≥ 19 yr of age) with moderate to severe OSA 
(AHI ≥ 15 events/hr at the sleep clinic in Ramathibodi hospital 
 - Study after EC approval to March, 2026 
- Patients with OSA who are prescribed CPAP therapy and 
accepted a trial of therapy 
Exclusion criteria 
- Patients deny to provide an informed consent  
- Patients had active cardiovascular, pulmonary, psychiatric disease, and 
epilepsy 
- Patients had been previously used CPAP for treatment of OSA 
- Patients have a problem to use a wearable device or watch 
- Patients had used any smartwatch before 
- Patients do not have a smart phone 
Patient was diagnosed with moderate to severe OSA (AHI > 15 
events/hours) and waiting process for CPAP (N = 80) 
Wearable group (N = 40) 
Control group (N = 40) 
Randomization by block randomization size = 4 
Lead in process: use wearable 
device for 2 weeks 
Standard care of CPAP with Garmin vivoactive 5 
with self-monitoring data 
Standard care of CPAP with Garmin vivoactive 5 
no self-monitoring data 
 
Data collection visit 1 
Data collection visit 1 
Data collection visit 2 
Data collection vivit 2 
Data analysis 
Data collection: 
From Garmin vivoactive 5: Sleep stage, total sleep time, HR, HRV, 
Oxygen saturation, sleep score, count steps 
From CPAP download: time used per day(min), %usage > 4 hr 
(%), AHI, leak, pressure 
 Questionnaires: ESS, PSQI 
4 weeks 
4 weeks 
8 weeks 
8 weeks 

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Academy of Sleep Medicine, diagnosed at the sleep clinic in 
Ramathibodi hospital 
2 Study between after EC approval to March, 2026 
3 Patients with OSA who are prescribed CPAP treatment and in the 
waiting process for their machine 
 
Exclusion criteria 
 
1 Patients deny to provide an informed consent 
2 Patients had active cardiovascular (ACS, arrythmias), pulmonary 
disease (ILD, COPD, PHT), psychiatric disease (insomnia, psychosis), 
and epilepsy 
3 Patients had been previously used CPAP for treatment of OSA 
4 Patients have a problem to use a wearable device or watch 
5 Patients had used any smartwatch before 
6 Patients do not have a smartphone 
Discontinuation/with
drawal criteria: 
 
1 Side effect of wearable device: allergy, discomfort from wearable device using 
2 Patients want to leave from the study 
Study Interventions/ 
procedures  
Using wearable device (Garmin vivoactive 5) with standard of care for CPAP  
- Wear it all day and night  
- The smartwatch can be removed at the convenience of the patient 
 
Why 
- Garmin vivoactive 5 is a wearable device that can detect data 
health from user and can feedback the data to user through 
Connect application. In this study hypothesis that the wearable 
device will help patients to improve CPAP adherence  
- Spec, price and there is a center in Thailand   
 
Materials 
Garmin vivoactive 5 with connect application and API health 
(request access from Garmin health with no expenses) 
 
Procedures 
Wearable group: Standard care of CPAP with Garmin vivoactive 5 
with self-monitoring data by connect the device to application 
(Connect application) 
 
Who 
provided 
Researcher, nurse who provide the information about standard of 
car for CPAP therapy 
 
How 
1. Lead-in Period 
     Patients who have been diagnosed with moderate to severe 
obstructive sleep apnea and are scheduled to receive continuous 
positive airway pressure (CPAP) therapy will be referred to the 
Sleep Clinic, 7th Floor, Phra Thep Building, Ramathibodi Hospital. 
At this clinic, the research team will provide detailed information 
about the study. If the patient agrees to participate, written 

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informed consent will be obtained. Participants will then be 
randomly assigned into one of two groups — the wearable 
device group or the control group — using block randomization. 
The allocation sequence will be prepared by a statistician and 
sealed in opaque envelopes to maintain allocation concealment. 
During this period, while waiting for CPAP device delivery from 
the supplier, participants will be asked to wear a Garmin 
Vivoactive 5 smartwatch to collect baseline data. They will also 
complete standardized questionnaires in Thai: the Epworth 
Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index 
(PSQI) to evaluate baseline sleepiness and sleep quality. 
2. Wearable Device Group (N = 40) 
     Participants in this group will receive a Garmin Vivoactive 5 
smartwatch and be instructed on its proper use. They will also 
learn how to access their health data via the Garmin Connect 
application, including sleep stages (light, deep, REM), heart rate, 
oxygen saturation, and daily step count. These data will be used 
to enhance patient engagement and support goal setting for 
personal health improvement. 
     Participants will continue to receive standard education and 
counseling regarding CPAP use, with an emphasis on adherence 
and motivation to achieve optimal health outcomes. 
3. Control Group (N = 40) 
     Participants in this group will also receive a Garmin Vivoactive 
5 smartwatch but will be informed that access to health data 
through the application will only be available during follow-up 
visits at the hospital. 
     Participants will not have direct access to the application, as 
login requires a password controlled by the research team. If a 
participant connects the device to another account, the research 
team will be able to detect it due to the creation of a new user 
profile, resulting in incomplete data continuity. 
     Patients will be able to view limited on-screen information, 
such as average oxygen saturation, sleep score, and step count. 
The screen brightness will be adjusted to the lowest level to 
minimize light exposure during sleep. 
     They will also receive standard CPAP education identical to 
the intervention group, encouraging consistent device use for 
optimal treatment benefits. 
4. Follow-Up Procedures 

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4.1 Week 1 and 2 (Telephone Follow-Up) 
     All participants will be contacted by telephone at Week 1 
and 2 to assess CPAP adherence, address difficulties, and provide 
additional guidance to promote usage of at least 4 hours per 
night. 
     Participants in the wearable group will be asked to capture 
screenshots from their Garmin Connect app and send them via 
the Sleep Center’s official LINE account. The data collected will 
include sleep stage distribution, total sleep time, heart rate, 
oxygen saturation, sleep score, and step count. 
4.2 Weeks 4 and 8 (Clinic Follow-Up) 
At Weeks 4 and 8, participants will attend in-person follow-up 
visits at the Sleep Clinic. 
Data collected will include: 
 From Garmin Connect: sleep stage, total sleep time, HR, 
oxygen saturation, sleep score, step count. 
 From CPAP device downloads: average usage time per 
day (minutes), % nights used >4h, AHI, leak, and pressure 
levels. 
At Week 8, participants will again complete ESS and PSQI (Thai 
versions) to evaluate post-intervention outcomes. 
5. Data Management and API Integration 
During the study, the research team will request access to Garmin 
Health API for raw data retrieval, which may be used for further 
research analysis or development of a web-based application for 
patient monitoring. 
6. Data Collection and Analysis 
All collected data will be compiled, cleaned, and analyzed 
according to the predefined statistical plan. 
7. End of Study Procedure 
At the end of the 8-week study period, participants will return 
the Garmin Vivoactive 5 smartwatch. The research team will 
verify data completeness, clean and reset the devices, and 
prepare them for use by subsequent participants. 
 
Where 
CPAP clinic at Sleep center Ramathibodi hospital 
 
When and 
How much 
January 2026 
After include patients  
- Follow up weekly by telephone for 2 week (Week 1 and 
2) 

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- Follow up at outpatient department at 4 and 8 weeks 
after inclusion 
 
Tailoring 
 
- 
 
Modifications - 
Comparator/Control  
 
Control group: Standard care of CPAP with Garmin vivoactive 5 without self-
monitoring data 
- Wear it all day and night  
- The smartwatch can be removed at the convenience of the patient 
- Patients will be able to view limited on-screen information, such as 
average oxygen saturation, step count, and sleep score. However, the 
screen brightness will be adjusted to the lowest possible level to 
minimize light 
- For connect application: Participants will not be able to access the 
application directly, as a password will be required for login. If a 
participant attempts to connect the smartwatch to another device, the 
research team will be notified, since a new account would need to be 
created, resulting in incomplete data continuity from the start of the 
study 
Allocation 
concealment 
mechanism 
By sealed letter to patients 
Implementation 
Moderate to severe OSA patients who receive treatment with CPAP therapy and 
accept for the consent will implement to clinical trial followed the protocol 
Blinding (masking): 
 
Care provider and Outcomes Assessor 
Participant timeline 
and Procedures:  
 
Assessment 
Waiting 
for CPAP 
Visit 1 by 
Telephone 
Visit 2 by 
telephone 
Visit 3 at 
OPD 
Visit 4 at 
OPD 
Informed 
consent 
X 
 
 
 
 
Demographics X 
 
 
 
 
Data 
collection 
 
X 
X 
X 
X 
Outcomes/endpoints
: 
 
Primary endpoint: Adherence for CPAP: time usage per day(min) and % usage > 4 
hours 
Secondary endpoint (s) 

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1 Access sleepiness and quality of sleep by questionnaire (ESS and PSQI) in Thai 
version 
2 Correlation between wearable-derived and CPAP data: Total sleep time(min), 
sleep stage (light, deep and REM) 
3 Health information: heart rate, oxygen saturation, stress, sleep score and step 
counting 
Harms/risks: 
Risk Mitigation: Skin Irritation or Allergic Reaction from Wearing the Device 
To minimize the risk of skin irritation or allergic reactions associated with wearing 
the smartwatch, the following precautions will be implemented: 
1. Participants will be instructed to wear the device loosely and remove it 
periodically to allow the skin to rest, especially in hot or humid 
conditions. 
2. Participants will be advised to clean and dry the skin and the device 
regularly according to the manufacturer’s guidelines. 
3. If any skin redness, itching, or rash occurs, participants will be instructed 
to immediately remove the device and contact the research team or 
their attending physician. 
4. The research team will document and monitor any adverse skin 
reactions, and appropriate medical evaluation and treatment will be 
provided as necessary. 
5. If the reaction is severe or persists, the participant may be withdrawn 
from the study for safety reasons. 
These measures are designed to ensure participant safety and to promptly 
manage any dermatologic adverse events related to device use. 
Adverse Event 
Reporting:  
Allergy from devices (CPAP, Garmin vivoactive 5) 
Data collection 
methods: 
1 Download data from CPAP and application Connect  
2 Questionnaires: ESS และ PSQI in Thai version 
3 Record form 
Compliance and 
adherence  
Check compliance by telephone at week 1 and week 2 and OPD visit at week 4 
and week 8 
Sample size 
determination: 
 
Sample size from the formular
 
Mean difference = 1.4 hr/night (7) 
SD = 2 
Α = 0.05 

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Power = 0.80 
N = 36 and drop out 10% N = 80 (wearable device group = 40, control group = 
40) 
Statistical Analysis 
Plan:  
 
1 The primary outcome will be analysed usage time of CPAP use using an Mean 
+/- SD (minutes) 
2 Secondary outcomes, including ESS and PSQI scores, will be analysed using t-
test or Mann-Whitney U tests. Pre- and post-intervention comparisons may utilize 
paired t-tests or ANCOVA to adjust for baseline differences 
3 A Pearson correlation will be used to assess relationship between wearable-
derived sleep metrics and CPAP adherence 
4 Intention-to-treat (ITT) and per-protocol (PP) analyses will be performed. The ITT 
analysis will serve as the primary approach to evaluate the overall effectiveness 
of the intervention in all randomized participants, while the PP analysis will be 
conducted as a secondary sensitivity analysis to assess the efficacy among 
participants who fully adhered to the study protocol.” 
4 Effect sizes and 95% confidence intervals will be reported 
5 All analyses will be performed using STATA, with p-value < 0.05 considered 
statistically significant 
Recruitment 
procedure: 
 
Ask patients from sleep clinic in Ramathibodi hospital 
Advice and explain the clinical trial protocol, if patients accept and consent, they 
will enter to clinical trial 
Informed Consent 
Process:  
 
  After patients accept to enter the clinical trial, they will sign the consent form 
and one copy of the document will be kept by the patient and one copy by the 
researcher 
 
Privacy and 
confidentiality (Data 
Management Plan) : 
Patient information will be coded and kept confidential, preventing access to 
individuals not involved in the research 

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Study Timeline: 
 
Study from January 2026 
1 Screen and enrollment from (2 week) 
2 Treatment phase (4 week and 8 week) 
3 Data collection and data analysis: 1 month  
Budget: 
 
1 Compensation for research participants 400 bath/person 
2 Garmin vivoactive 5 4,999.04 bath/unit  
3 Development application 385,200 bath 
Total price 597,165.44 bath 
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