Obstructive Sleep Apnea of AdultNCT06603441
Reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea of Adult, run by Stanford University at 1 site in United States.
Trial summary
The study will test the reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea (OSA) Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Samsung Galaxy Watch
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to 23 Dec 2025
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patient's visiting Stanford Hospital and Clinics 2. Digital Recruitment - online advertisement campaign
Who may be able to join
- 22 years of age or older
- High pre-test likelihood of moderate to severe obstructive sleep apnea (OSA) based on screening questionnaires (STOP-Bang and Epworth Sleepiness Scale); or prior diagnosis of moderate-severe OSA.
- Able to provide informed consent confirmation
Who cannot join
- Severe and/or other acute medical illnesses as determined by the Investigator, in particular: Cardiac conditions such as Congestive Heart Failure (CHF), atrial fibrillation, Hx of Movement disorders: Parkinson's, Tremor, Lung conditions: Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, emphysema, pulmonary fibrosis, acute episode of flu, allergies, asthma.
- Active comorbid sleep disorders, such as severe insomnia, restless legs syndrome, Periodic Leg Movement During Sleep (PLMS), narcolepsy, idiopathic hypersomnia
- Severe and/or unstable psychiatric disorders such as mood, anxiety, or psychotic disorders
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
- Inability to use a Samsung Galaxy device for sleep tracking
- Inability to have two nights in the Stanford sleep lab.
- Participants who are pregnant
- Tattoos or scars covering the forearm area of both hands
Trial locations and contacts
1 site in 1 country.
About this study
The study will test the reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea (OSA)
Read the detailed description
A prospective cohort of 150 individuals 22 years or older with a prior diagnosis or with a high likelihood of having moderate to severe OSA, screened using STOP-Bang and Epworth Sleepiness Scale questionnaires will be recruited and will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Samsung Galaxy Watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samsung Galaxy WatchDiagnostic test
Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters.
| Study group | Role | What they receive |
|---|---|---|
| Samsung Galaxy Watch technology | All participants screened will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights Receives: Diagnostic Test: Samsung Galaxy Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
4% Apnea Hypopnea Index (AHI)
Assessment of the 4% Apnea Hypopnea Index to determine the severity of sleep apnea
Measured: Day 1 (Visit 1), Day 5 (Visit 2)
Secondary outcomes (1)
User acceptance and feasibility of Galaxy Watch technology
Evaluation of,
- Ease of use (scored from 1-5, where 1 indicates low ease of use and 5 indicates high ease of use)
- Comfort (scored from 1-5, where 1 indicates low comfort and 5 indicates high comfort)
- Compliance (dropout rate and the number of nights and hours of sleep recorded for each participant)
Measured: Day 1 (Visit 1), Day 5 (Visit 2), At home monitoring (Day 2, 3 &4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Dec 2024
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Robson Capasso, Stanford University
- Investigators
- Robson Capasso, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603441
- Sponsor's protocol ID
- 76129
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alavi A, Costa E, Matsumoto MMS, Odenwald N, Elkarra N, Ma Y, Taweesedt PT, Kawai M, Kushida C, Capasso R. Smartwatch-based detection of moderate-to-severe and high-risk obstructive sleep apnea. J Clin Sleep Med. 2026 Aug 27;22(1):150. doi: 10.1007/s44470-026-00159-8.
PubMed 42661136Alavi A, Costa E, Matsumoto MMS, Odenwald N, Kushida C, Bahmani A, Capasso R. Comprehensive Evaluation of Night-to-Night Variability in Polysomnography Metrics and Apnea-Hypopnea Index-Based Diagnostic Reclassification. Chest. 2026 Jun 16:S0012-3692(26)00782-8. doi: 10.1016/j.chest.2026.06.004. Online ahead of print.
PubMed 42302984
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06603441
- Acronym / sponsor ID
- 76129
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 19 Sep 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 study will test the reliability of the Samsung Galaxy for the Detection of Moderate to Severe Obstructive Sleep Apnea (OSA)
Detailed description
A prospective cohort of 150 individuals 22 years or older with a prior diagnosis or with a high likelihood of having moderate to severe OSA, screened using STOP-Bang and Epworth Sleepiness Scale questionnaires will be recruited and will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samsung Galaxy Watch technology | – | Diagnostic Test: Samsung Galaxy WatchAll participants screened will utilize the Samsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. All data will be collected over the course of two intervention nights in the sleep lab and at home for three nights |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patient's visiting Stanford Hospital and Clinics 2. Digital Recruitment - online advertisement campaign
Key inclusion criteria (3 listed)
- 22 years of age or older
- High pre-test likelihood of moderate to severe obstructive sleep apnea (OSA) based on screening questionnaires (STOP-Bang and Epworth Sleepiness Scale); or prior diagnosis of moderate-severe OSA.
- Able to provide informed consent confirmation
Key exclusion criteria (8 listed)
- Severe and/or other acute medical illnesses as determined by the Investigator, in particular: Cardiac conditions such as Congestive Heart Failure (CHF), atrial fibrillation, Hx of Movement disorders: Parkinson's, Tremor, Lung conditions: Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, emphysema, pulmonary fibrosis, acute episode of flu, allergies, asthma.
- Active comorbid sleep disorders, such as severe insomnia, restless legs syndrome, Periodic Leg Movement During Sleep (PLMS), narcolepsy, idiopathic hypersomnia
- Severe and/or unstable psychiatric disorders such as mood, anxiety, or psychotic disorders
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
- Inability to use a Samsung Galaxy device for sleep tracking
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 |
|---|---|---|
| Samsung Galaxy WatchSamsung Galaxy Watch technology to monitor sleep patterns, oxygen saturation, PPG, and heart rate variability amongst other physiologic parameters. | Diagnostic test | Samsung Galaxy Watch technology |
Primary outcome
4% Apnea Hypopnea Index (AHI)
Time frame: Day 1 (Visit 1), Day 5 (Visit 2)
Assessment of the 4% Apnea Hypopnea Index to determine the severity of sleep apnea
1 secondary outcome
User acceptance and feasibility of Galaxy Watch technology
Time frame: Day 1 (Visit 1), Day 5 (Visit 2), At home monitoring (Day 2, 3 &4)
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 15 Apr 2026.
- Derived from this study: PubMed 42661136Alavi A, Costa E, Matsumoto MMS, Odenwald N, Elkarra N, Ma Y, Taweesedt PT, Kawai M, Kushida C, Capasso R. Smartwatch-based detection of moderate-to-severe and high-risk obstructive sleep apnea. J Clin Sleep Med. 2026 Aug 27;22(1):150. doi: 10.1007/s44470-026-00159-8.
- Derived from this study: PubMed 42302984Alavi A, Costa E, Matsumoto MMS, Odenwald N, Kushida C, Bahmani A, Capasso R. Comprehensive Evaluation of Night-to-Night Variability in Polysomnography Metrics and Apnea-Hypopnea Index-Based Diagnostic Reclassification. Chest. 2026 Jun 16:S0012-3692(26)00782-8. doi: 10.1016/j.chest.2026.06.004. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Robson Capasso, MD principal investigator
Stanford University
1 site 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 of Adult, run by Stanford University at 1 site in United States.
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 3 inclusion and 8 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 15 Apr 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 United States. 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?
4% Apnea Hypopnea Index (AHI) (time frame: Day 1 (Visit 1), Day 5 (Visit 2)). 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 NCT06603441, which also lists 2 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 Apr 2026.