Obstructive Sleep ApneaNCT06540716
Inspire Singapore Study
A study testing Inspire System in people with Obstructive Sleep Apnea and OSA, run by Inspire Medical Systems, Inc. at 2 sites in Singapore.
Trial summary
Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, OSA, Sleep Apnea
- What is being tested?
- Inspire System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesSingapore
- Study dates
- 25 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Diagnosis of moderate to severe OSA (AHI 15-65)
- Failure of, or intolerance to CPAP
Main Exclusion Criteria:
- Central + mixed apneas > 25% of total AHI
- Presence of complete concentric collapse (CCC)
- Compromised neurological control of the upper airway.
Other eligibility criteria may apply.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital
Singapore
Singapore General Hospital
Singapore
About this study
Official title: Inspire Singapore Study: Confirmation of Therapy Performance
Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.
Read the detailed description
Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.
- Conditions
- Obstructive Sleep Apnea, OSA, Sleep Apnea
- Being tested
- Inspire System
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspire SystemDevice
Hypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant.
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal nerve stimulation | Other | Not described Receives: Device: Inspire System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Overlap
Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)
Measured: 0-3 months post-therapy activation
Secondary outcomes (2)
Therapy Effectiveness
Change in Apnea-Hypopnea Index (AHI)
Measured: 6 months post-therapy activation
Symptom Reduction
Mean Epworth Sleepiness Scale (ESS) Score of less than 10. ESS scores range from 0-24 with a score of less than 10 indicating normalized daytime sleepiness.
Measured: 6 months post-therapy activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start25 Jul 2024
- Primary completion17 Jul 2025
- Study completion1 Dec 2025
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toh Song Tar, MD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540716
- Sponsor's protocol ID
- 2022-001
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspire Singapore Study: Confirmation of Therapy Performance
- ClinicalTrials.gov ID
- NCT06540716
- Acronym / sponsor ID
- 2022-001
- Conditions
- Obstructive Sleep Apnea, OSA, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 6 Aug 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.
Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.
Detailed description
Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoglossal nerve stimulation | Other | Device: Inspire System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Inspire SystemHypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant. | Device | Hypoglossal nerve stimulation |
Primary outcome
Inspiratory Overlap
Time frame: 0-3 months post-therapy activation
Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)
2 secondary outcomes
Therapy Effectiveness
Time frame: 6 months post-therapy activation
Symptom Reduction
Time frame: 6 months post-therapy activation
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 22 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
Toh Song Tar, MD principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspire System in people with Obstructive Sleep Apnea and OSA, run by Inspire Medical Systems, Inc. at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Inspiratory Overlap (time frame: 0-3 months post-therapy activation). 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 22 May 2026.