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First Line Obstructive Sleep Apnea Treatment Study (FLOSAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University Hospital, Antwerp

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 121 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Mandibular advancement device
Active therapy
Device: Mandibular advancement device (MAD)
Active therapy
Other Name: EVO Prosomnus

Continuous positive airway pressure
Active therapy
Device: Continuous positive airway pressure (CPAP)
Active therapy
Other Name: Philips Respironics - Dreamstation

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT05393531

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Contact: Olivier Vanderveken, MD, PhD 038213385 ext 0032
Contact: Marijke Dieltjens, PhD 038215221

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Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Olivier Vanderveken, MD, PhD    038213385 ext 0032   
Contact: Marijke Dieltjens, PhD    038215221 ext 0032   
Sub-Investigator: Shouresh Charkendeh, DDS         
Sub-Investigator: Marc Braem, DDS, PhD         
Sub-Investigator: Karlien Vandenbossche, MD         
Sponsors and Collaborators
University Hospital, Antwerp
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Responsible Party: University Hospital, Antwerp Identifier: NCT05393531    
Other Study ID Numbers: B300202100205
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Antwerp:
Mandibular Advancement Device
Continuous Positive Airway Pressure
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases