Device performance evaluation for obstructive sleep apnea treatment in Singapore
Inspire Singapore Study: Confirmation of Therapy Performance
NA · Inspire Medical Systems, Inc. · NCT06540716
This study is testing how well the Inspire device works for treating obstructive sleep apnea in Singapore patients over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Inspire Medical Systems, Inc. (industry) |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT06540716 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, multicenter, open-label evaluation of the Inspire system for treating obstructive sleep apnea (OSA) in Singapore. Eligible patients will receive the Inspire device and will be monitored for six months post-therapy activation. Participants will undergo a series of in-lab sleep studies to assess therapy effectiveness and adjust treatment as necessary. Additionally, the study will collect data on symptoms, quality of life, therapy adherence, and any adverse events experienced during the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with moderate to severe obstructive sleep apnea who have failed or are intolerant to CPAP treatment.
Not a fit: Patients with central or mixed apneas comprising more than 25% of their total apnea-hypopnea index, or those with complete concentric collapse of the airway, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative treatment for patients with moderate to severe OSA who are unable to tolerate CPAP therapy.
How similar studies have performed: Other studies evaluating the Inspire system have shown promising results, indicating that this approach is gaining traction in the treatment of obstructive sleep apnea.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore and 1 other locations
- National University Hospital — Singapore, Singapore (RECRUITING)
- Singapore General Hospital — Singapore, Singapore (RECRUITING)
Study contacts
- Principal investigator: Toh Song Tar, MD — Singapore General Hospital
- Study coordinator: Gwen Gimmestad
- Email: gwengimmestad@inspiresleep.com
- Phone: 763-392-9966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, OSA, Sleep Apnea