Obstructive Sleep Apnea, OSA, Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICEInspire System
Hypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant.
Sponsors
Inspire Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Overlap | 0-3 months post-therapy activation | Percentage (%) of inspiratory overlap as measured by polysomnography (PSG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapy Effectiveness | 6 months post-therapy activation | Change in Apnea-Hypopnea Index (AHI) |
| Symptom Reduction | 6 months post-therapy activation | 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. |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORToh Song Tar, MD
Singapore General Hospital
Outcome results
None listed