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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE November 24, 2021
First Posted Date  ICMJE May 26, 2022
Last Update Posted Date May 26, 2022
Actual Study Start Date  ICMJE November 9, 2021
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2022)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2022)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Line Obstructive Sleep Apnea Treatment Study
Official Title  ICMJE Comparison of First Line Non-invasive Treatment Options in Patients Diagnosed With Obstructive Sleep Apnea
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.

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 airway during sleep. This can cause intermittent breathing cessation during sleep, which leads to oxygen desaturation and micro-arousals during the night and eventually sleep fragmentation. Due to these perturbations, OSA is linked to a range of harmful sequelae: excessive daytime sleepiness, fatigue, an impaired cognitive performance, a reduced quality of life, an increased risk of occupational and traffic accidents, metabolic disturbances, hypertension, cardio- and cerebrovascular morbidity and OSA-related mortality. OSA severity is characterized by the apnea-hypopnea index (AHI), representing the amount of apneas and hypopneas during at least ten seconds, per hour of sleep. When studying OSA, one can also use the obstructive apnea-hypopnea index (OAHI) leaving out any central apnea component.

Due to the high prevalence as well as the individual and socioeconomic healthcare issues related to OSA, effective management of this chronic disorder is imperative. Continuous positive airway pressure (CPAP) is typically recommended as first line therapy for moderate to severe OSA, applying pressurized air throughout the respiratory cycle to keep the upper airway patent. Although CPAP is highly efficacious in reducing the severity of OSA, the clinical effectiveness is often compromised by a low patient acceptance and suboptimal adherence.

The alternative non-invasive treatment option is the use of a mandibular advancement device (MAD): this type of oral appliance protrudes the mandible during sleep, thereby enlarging and stabilizing the upper airway. The efficacy of MAD therapy in terms of reduction in AHI is demonstrated in clinical trials but turns out to be less efficacious compared to that obtained with CPAP. However, this suboptimal efficacy is counterbalanced by a higher compliance rate and relatively low discontinuation rate.

Nevertheless, studies comparing MAD with CPAP therapy outcomes show that both therapies are equally effective in reducing blood pressure and in reducing cardiovascular death. This might be explained by the greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar clinical effectiveness. However, such studies are generally lacking objective compliance measurements for MAD therapy.

At this moment, different models of CPAP machines made by Philips Respironics were recalled in June 2021 due to a potential health risk: the polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device's air pathway. If this occurs, black debris from the foam or certain chemicals released into the device's air pathway may be inhaled or swallowed by the patient using the device. This indirectly implicates that there is a supply chain problem regarding new CPAP devices for patients recently diagnosed with moderate to severe OSA, and that those patients stay untreated until this supply chain problem is resolved. Up till now, this time frame is unclear.

Study protocol The investigators will perform a crossover clinical trial comparing the overall effectiveness of MAD therapy with the effectiveness of CPAP therapy in terms of reduction in OAHI.

The investigators will include patients that are diagnosed with moderate to severe OSA (obstructive AHI ≥ 15 events/hour of sleep and < 65 events/hour of sleep), body mass index < 35 kg/m² and put on the waiting list to receive CPAP therapy but that underwent the CPAP titration night.

Those patients will be invited to start MAD therapy with a custom-made titratable MAD (ProSomnus EVO, ProSomnus, Pleasanton, CA, USA). The MAD devices will be provided free of charge and an active thermomicrosensor (Theramon, IFT Handels- und Entwicklungsgesellschaft GmbH, Handelsagentur Gschladt) will be embedded to objectively measure the adherence to MAD therapy. The patients are then treated according to routine clinical practice: after three months of MAD use, the efficacy of the therapy in terms of reduction in OSA severity will be evaluated in the real life setting by using a portable home sleep test. The objective adherence will be read out from the thermomicrosensor, in order to be able to calculate the overall clinical effectiveness of this given therapy.

After this objective evaluation of the clinical effectiveness of MAD therapy, a wash-out period of one week is integrated in the protocol. Thereafter, when CPAP devices are available again and at least three months after the start of MAD therapy, patients will start with CPAP therapy. After three months of CPAP use, the efficacy in terms of reduction in OSA severity will be evaluated in the real life setting by using a portable home sleep test. Also, the objective adherence will be read out using the built-in registration data, to calculate the overall clinical effectiveness.

At the end of the study, patients will be questioned regarding their treatment preference: do they prefer CPAP, MAD or do they have no preference at all.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Sequential
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Device: Mandibular advancement device (MAD)
    Active therapy
    Other Name: EVO Prosomnus
  • Device: Continuous positive airway pressure (CPAP)
    Active therapy
    Other Name: Philips Respironics - Dreamstation
Study Arms  ICMJE
  • Mandibular advancement device
    Active therapy
    Intervention: Device: Mandibular advancement device (MAD)
  • Continuous positive airway pressure
    Active therapy
    Intervention: Device: Continuous positive airway pressure (CPAP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2022)
121
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05393531
Other Study ID Numbers  ICMJE B300202100205
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Hospital, Antwerp
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Antwerp
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Antwerp
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP