Obstructive Sleep ApneaNCT06633887
TipTraQ Home Sleep Test Study, SHH
An observational study of Obstructive Sleep Apnea, run by PranaQ Pte. Ltd. at 1 site in Taiwan.
Trial summary
The clinical study aims to develop and validate the TipTraQ system, created by PranaQ, a home sleep test for sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and Apnea-Hypopnea Index (AHI). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 27 Mar 2024
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy or people who has indication to conduct polysomnography (PSG).
Who may be able to join
- Subjects from the age of 20 and older that have an indication for an in-lab PSG study.
Who cannot join
- Heart transplant
- Heart failure, New Youk Heart Association (NYHA) classification III or IV
- Chronic opioid medication user
- Devastating severe strokes, with the modified Rankin score (mRS)≥4
- Tracheostomy
- Incapable of comprehending and signing the informed consent and questionnaires, including but not limited to subjects with severe Alzheimer's, unconscious by head trauma, or of someone with limited mental capacity
- Cannot correctly follow the order to use the TipTraQ device
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
About this study
Official title: Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography
The clinical study aims to develop and validate the TipTraQ system, created by PranaQ, a home sleep test for sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and Apnea-Hypopnea Index (AHI).
Read the detailed description
Sleep-disordered breathing is a common disease that affects life function and quality of life, and it also imposes a great burden on the public health system. Obstructive sleep apnea accounts for the largest proportion of sleep-disordered breathing, and because of the oriental facial structure, the prevalence of sleep-disordered breathing is relatively high. The current gold standard for diagnosis OSA is polysomnography (PSG). Although the physiological information collected by PSG is complete and detailed, it requires a considerable amount of manpower and medical resources, and changes in the sleep environment also cause bias in the accuracy of inspection. So far, the tools for simple and accurate screening and diagnosis OSA are relatively limited. In this study, TipTraQ, a wearable device developed by PranaQ, was used to collect photoplethysmography (PPG) of patients during the night of PSG inspection. The reliability and validity analysis was carried out by comparing with the corresponding indicators of PSG, and the feasibility of TipTraQ as a tool for home sleep test (HST).
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy or people who has indication to conduct polysomnography (PSG). | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index(AHI)
The combined average number of apneas and hypopneas that occur per hour of sleep
Measured: From the start of a single polysomnography study to the end of the recording, 1 night.
Oxygen Desaturation Index(ODI)
Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour
Measured: From the start of a single polysomnography study to the end of the recording, 1 night.
Total Sleep Time(TST)
Total sleep time during the polysomnography (PSG)
Measured: From the start of a single polysomnography study to the end of the recording, 1 night.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Mar 2023
- Primary completion28 Feb 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- PranaQ Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633887
- Sponsor's protocol ID
- TipTraQ developement SHH
- Other IDs
- N202303101
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen KW, Tseng CH, Lee HC, Liu WT, Chou KT, Wu HT. Validation of a fingertip home sleep apnea testing system using deep learning AI and a temporal event localization analysis. Sleep. 2025 May 12;48(5):zsae317. doi: 10.1093/sleep/zsae317.
PubMed 39821673
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography
- ClinicalTrials.gov ID
- NCT06633887
- Acronym / sponsor ID
- TipTraQ developement SHH
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- PranaQ Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 9 Oct 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 clinical study aims to develop and validate the TipTraQ system, created by PranaQ, a home sleep test for sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and Apnea-Hypopnea Index (AHI).
Detailed description
Sleep-disordered breathing is a common disease that affects life function and quality of life, and it also imposes a great burden on the public health system. Obstructive sleep apnea accounts for the largest proportion of sleep-disordered breathing, and because of the oriental facial structure, the prevalence of sleep-disordered breathing is relatively high. The current gold standard for diagnosis OSA is polysomnography (PSG). Although the physiological information collected by PSG is complete and detailed, it requires a considerable amount of manpower and medical resources, and changes in the sleep environment also cause bias in the accuracy of inspection. So far, the tools for simple and accurate screening and diagnosis OSA are relatively limited. In this study, TipTraQ, a wearable device developed by PranaQ, was used to collect photoplethysmography (PPG) of patients during the night of PSG inspection. The reliability and validity analysis was carried out by comparing with the corresponding indicators of PSG, and the feasibility of TipTraQ as a tool for home sleep test (HST).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy or people who has indication to conduct polysomnography (PSG). | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy or people who has indication to conduct polysomnography (PSG).
Key inclusion criteria (1 listed)
- Subjects from the age of 20 and older that have an indication for an in-lab PSG study.
Key exclusion criteria (7 listed)
- Heart transplant
- Heart failure, New Youk Heart Association (NYHA) classification III or IV
- Chronic opioid medication user
- Devastating severe strokes, with the modified Rankin score (mRS)≥4
- Tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apnea Hypopnea Index(AHI)
Time frame: From the start of a single polysomnography study to the end of the recording, 1 night.
The combined average number of apneas and hypopneas that occur per hour of sleep
Oxygen Desaturation Index(ODI)
Time frame: From the start of a single polysomnography study to the end of the recording, 1 night.
Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour
Total Sleep Time(TST)
Time frame: From the start of a single polysomnography study to the end of the recording, 1 night.
Total sleep time during the polysomnography (PSG)
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 18 Oct 2024.
- Derived from this study: PubMed 39821673Chen KW, Tseng CH, Lee HC, Liu WT, Chou KT, Wu HT. Validation of a fingertip home sleep apnea testing system using deep learning AI and a temporal event localization analysis. Sleep. 2025 May 12;48(5):zsae317. doi: 10.1093/sleep/zsae317.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Obstructive Sleep Apnea, run by PranaQ Pte. Ltd. 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 1 inclusion and 7 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 18 Oct 2024. 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?
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?
Apnea Hypopnea Index(AHI) (time frame: From the start of a single polysomnography study to the end of the recording, 1 night.). The study lists 3 primary outcomes in all. 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 NCT06633887, which also lists 1 linked publication.
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 18 Oct 2024.