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NCT05393531: FLOSAT
First Line Obstructive Sleep Apnea Treatment Study
Phase 4 trial testing Mandibular advancement device (MAD) in Obstructive Sleep Apnea in 136 participants. Completed in 30 June 2024.
25 January 2024
Quick facts
| Lead sponsor | University Hospital, Antwerp |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 136 |
| Start date | 9 November 2021 |
| Primary completion | 25 January 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Mandibular advancement device (MAD)
- Continuous positive airway pressure (CPAP)
Conditions studied
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Sponsor
University Hospital, Antwerp
Who can join
Adults 18 to 99, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective is to evaluate the overall effectiveness of MAD therapy as a first line treatment, including both efficacy in terms of reduction in OSA severity as well as objective compliance, in patients recently diagnosed with moderate to severe OSA, waiting for a new CPAP device. Upon completion of MAD-therapy, patients will be put on CPAP, allowing for comparison of MAD effectiveness versus the overall therapeutic effectiveness of CPAP therapy in the same patient. Finally, patients' preference for either therapy will be evaluated.
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 NCT05393531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mandibular advancement device (MAD)
Trials testing the same drug.
- NCT07132307 — Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement · NA · recruiting
Other recruiting trials for Obstructive Sleep Apnea
Currently open trials in the same condition.
- NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
- NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
- NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
- NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
- NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting
Other University Hospital, Antwerp trials
Trials by the same sponsor.
- NCT07455422 — A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurr · NA · not yet recruiting
- NCT07020715 — A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis · Phase 2 · not yet recruiting
- NCT07443761 — Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital. · active not recruiting
- NCT06372847 — DISE-HNS Effect Study · NA · recruiting
- NCT07189091 — CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS · Phase 4 · 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 NCT05393531 (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, Antwerp
- Last refreshed: 14 February 2025
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/NCT05393531.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing