Obstructive Sleep Apnea Clinical Trial
— FLOSATOfficial title:
Comparison of First Line Non-invasive Treatment Options in Patients Diagnosed With Obstructive Sleep Apnea
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.
Status | Recruiting |
Enrollment | 121 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - dental status not good enough for MAD therapy |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall therapeutic effectiveness of MAD and CPAP | Combination of adherence (hours use per night) and efficacy (decrease in apnea/hypopnea index measured during a polysomnography) | 3 months after start of the therapy (either MAD or CPAP) | |
Secondary | Treatment preference by questionnarie: which treatment do you prefer: CPAP, MAD or none? | Preference of the patients for one of the two given therapies | 6 months |
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