First Line Obstructive Sleep Apnea Treatment Study (FLOSAT)
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|ClinicalTrials.gov Identifier: NCT05393531|
Recruitment Status : Unknown
Verified November 2021 by University Hospital, Antwerp.
Recruitment status was: Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Mandibular advancement device (MAD) Device: Continuous positive airway pressure (CPAP)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||121 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Sequential|
|Masking:||None (Open Label)|
|Official Title:||Comparison of First Line Non-invasive Treatment Options in Patients Diagnosed With Obstructive Sleep Apnea|
|Actual Study Start Date :||November 9, 2021|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Mandibular advancement device
Device: Mandibular advancement device (MAD)
Other Name: EVO Prosomnus
Continuous positive airway pressure
Device: Continuous positive airway pressure (CPAP)
Other Name: Philips Respironics - Dreamstation
- Overall therapeutic effectiveness of MAD and CPAP [ Time Frame: 3 months after start of the therapy (either MAD or CPAP) ]Combination of adherence (hours use per night) and efficacy (decrease in apnea/hypopnea index measured during a polysomnography)
- Treatment preference by questionnarie: which treatment do you prefer: CPAP, MAD or none? [ Time Frame: 6 months ]Preference of the patients for one of the two given therapies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05393531
|Contact: Olivier Vanderveken, MD, PhD||038213385 ext email@example.com|
|Contact: Marijke Dieltjens, PhDfirstname.lastname@example.org|
|Antwerp University Hospital||Recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Olivier Vanderveken, MD, PhD 038213385 ext 0032 email@example.com|
|Contact: Marijke Dieltjens, PhD 038215221 ext 0032 firstname.lastname@example.org|
|Sub-Investigator: Shouresh Charkendeh, DDS|
|Sub-Investigator: Marc Braem, DDS, PhD|
|Sub-Investigator: Karlien Vandenbossche, MD|