Status:
COMPLETED
First Line Obstructive Sleep Apnea Treatment Study
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Obstructive sleep apnea (OSA) is a highly prevalent disorder, affecting up to 17% of middle-aged men. OSA is characterized by repetitive narrowing (hypopnea) or complete collapse (apnea) of the upper ...
Eligibility Criteria
Inclusion
- oAHI ≥ 15 events/hour of sleep and \< 65 events/hour of sleep
- BMI \< 35 kg/m²
- waiting list to receive CPAP therapy but underwent the CPAP titration night
Exclusion
- dental status not good enough for MAD therapy
Key Trial Info
Start Date :
November 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05393531
Start Date
November 9 2021
End Date
June 30 2024
Last Update
February 14 2025
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650