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NCT03844295: AIRSTIM
Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve
NA trial testing Activated Inspire® Upper Airway Stimulation System in Obstructive Sleep Apnea Syndrome in 7 participants. Completed in 10 October 2023.
22 December 2021
Quick facts
| Lead sponsor | University Hospital, Grenoble |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 21 March 2019 |
| Primary completion | 22 December 2021 |
| Estimated completion | 10 October 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Activated Inspire® Upper Airway Stimulation System
- Inactivated Inspire® Upper Airway Stimulation System
Conditions studied
- Obstructive Sleep Apnea Syndrome — all drugs for Obstructive Sleep Apnea Syndrome →
Sponsor
University Hospital, Grenoble
Who can join
Adults 18 to 80, any sex, with Obstructive Sleep Apnea Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation. The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03844295
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Obstructive Sleep Apnea Syndrome
Currently open trials in the same condition.
- NCT05147649 — Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome · NA · recruiting
Other University Hospital, Grenoble trials
Trials by the same sponsor.
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- NCT07379372 — Bladder Overactivity and Post-Botulinum Toxin Telemonitoring · NA · not yet recruiting
- NCT07166991 — Anesthesia sTrategy foR Organ Procurement In braiN dEath · Phase 3 · recruiting
- NCT07367880 — The Monument Test : A New Tool for Assessing the Ability to Name and Identify Unique Entities. (TeDIMO) · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03844295 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Grenoble
- Last refreshed: 26 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03844295.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing