First Line Obstructive Sleep Apnea Treatment Study

NCT05393531 | Completed Phase 4

• 1 other identifier: B300202100205
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Mandibular Advancement Device; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment preference by questionnarie: which treatment do you prefer: CPAP, MAD or none?

  6 months

Study Arms (2)

Mandibular advancement device

OTHER

Active therapy

Device: Mandibular advancement device (MAD)

Continuous positive airway pressure

OTHER

Active therapy

Device: Continuous positive airway pressure (CPAP)

Interventions

Mandibular advancement device (MAD) DEVICE

Active therapy

Also known as: EVO Prosomnus

Mandibular advancement device

Continuous positive airway pressure (CPAP) DEVICE

Active therapy

Also known as: Philips Respironics - Dreamstation

Continuous positive airway pressure

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• dental status not good enough for MAD therapy

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: May 26, 2022
• Study Start: November 9, 2021
• Primary Completion: January 25, 2024
• Study Completion: June 30, 2024
• Last Updated: February 14, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)