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NCT03210142: Lingual
Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)
NA trial testing Transvenous hypoglossal nerve stimulation in Sleep Apnea, Obstructive in 23 participants. Completed in 31 July 2018.
8 February 2018
Quick facts
| Lead sponsor | Medtronic Cardiac Rhythm and Heart Failure |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 23 |
| Start date | 23 June 2017 |
| Primary completion | 8 February 2018 |
| Estimated completion | 31 July 2018 |
| Sites | 3 locations across Hong Kong |
Drugs / interventions tested
- Transvenous hypoglossal nerve stimulation
Conditions studied
- Sleep Apnea, Obstructive — all drugs for Sleep Apnea, Obstructive →
Sponsor
Medtronic Cardiac Rhythm and Heart Failure — full company profile →
Who can join
18 and older, any sex, with Sleep Apnea, Obstructive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause contraction of the genioglossus muscle, which will move the tongue forward, opening the upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that require an open surgical approach to wrap a cuff electrode around the HGN.
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 NCT03210142
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sleep Apnea, Obstructive
Currently open trials in the same condition.
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- NCT07176767 — The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents · recruiting
- NCT06573372 — Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea · recruiting
- NCT06848647 — Treatment of Sleep Apnea to Improve Metabolic Health · recruiting
Other Medtronic Cardiac Rhythm and Heart Failure trials
Trials by the same sponsor.
- NCT06910059 — The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Ech · active not recruiting
- NCT06745778 — Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D · recruiting
- NCT06540521 — Bolt CSP-M Holter Study · recruiting
- NCT06038123 — China 3T MRI Study · NA · completed
- NCT06089694 — Crome/Cobalt Respiration Study · completed
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 NCT03210142 (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 Medtronic Cardiac Rhythm and Heart Failure
- Last refreshed: 17 August 2018
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/NCT03210142.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing