Benefit, Usage and Comfort of Treatment of OSA With a Mandibular Advancement Device: Narval Registry

Overview

During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2020

Detailed Description

During sleep, the muscles in the oropharyngeal space relax, the tongue falls back and the volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Diminishing airflow can lead to snoring or to the airways collapsing completely (obstructive sleep apnea, OSA). Patients who suffer from OSA have trouble breathing during sleep and will have a disturbed sleep architecture as repeated airway closure causes wake reactions and arousals. This does not only lead to severe daytime sleepiness with high risk of causing car accidents, for instance, but also affects synaptic activity during sleep and the balance of blood gas levels. These factors can have a aggravating effect on blood pressure and worsen the prognosis for cardiovascular comorbidities. First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Positive airway pressure is being applied through a facial mask and some patients cannot tolerate this therapy or refuse it. An alternative treatment approach is by fitting an MAD that the patient wears during sleep. An MAD pushes the lower jar forward and thereby increases the volume of the upper airways, thus preventing them to close. Studies have shown good compliance with MAD therapy and benefits in terms of sleepiness and quality of life. The Narval registry study aims to investigate MAD usage in real life and reasons for non-compliance. The registry aims to record patient characteristics (e.g. comorbidities) and side effects that lead to a termination of therapy, but also how the costs for therapy are split between the patient and public or private health insurance providers and how this affects therapy initiation and usage.

Clinical Trial Outcome Measures

Primary Measures

  • Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months
    • Time Frame: 3 months
    • Changes in the number of apnoeas (cessation of airflow) and hypopneas (reduced airflow) at baseline and at follow-up

Secondary Measures

  • Changes in quality of life from baseline compared to 3 months follow-up
    • Time Frame: 3 months
    • Changes in quality of life assessed with the questionnaire EQ-5D (EuroQoL 5-D measures the health status of a patient as self-reported outcome)
  • Changes in daytime sleepiness from baseline compared to 3 months follow-up
    • Time Frame: 3 months
    • Changes in daytime sleepiness assessed with the Epworth Sleepiness Scale questionnaire (ESS, measures the likelihood of a patient of falling asleep during daytime as self-reported outcome)
  • Changes in snoring from baseline compared to 3 months follow-up
    • Time Frame: 3 months
    • Changes in snoring assessed with a snoring questionnaire (the Thornton Snoring Scale contains 5 questions about snoring as subjective patient`s measure)
  • Usage of the Narval MAD (mandibular advancement device)
    • Time Frame: 3 months
    • Patients will be asked about how long and on how many days they were using the Narval MAD during the follow-up period. Patients will be offered a choice between “usage in total” – every night, 3-4 times a week, 1-2 times a week. Usage per night: Less than 1 hour, 1-3 hours, 4-5 hours.
  • Side effects with use of the Narval MAD (mandibular advancement device)
    • Time Frame: 3 months
    • Patients will be asked if they experienced side effects and which kind of side effects: Temporomandibular joint pain, dental pain, hypersalivation, dry mouth, local irritation, inflammation, dental fracture, broken MAD/device defect.
  • Document comorbidities of enrolled patients
    • Time Frame: 3 months
    • Patients will be asked for relevant comorbidities (diabetes, hypertension, heart failure)
  • Remuneration of a Narval MAD
    • Time Frame: 3 months
    • Patients will be asked whether they bought the Narval MAD themselves or if a public or private healthcare insurance provider paid the expenses
  • Satisfaction with therapy
    • Time Frame: 3 months
    • Patients will be asked to rate their satisfaction with therapy on a scale of 1 (bad) to 10 (very good).
  • Document sleep disorders of enrolled patients
    • Time Frame: 3 months
    • Sleep disorders will be recorded with a polygraphy or polysomnography (obstructive sleep apnoea, central sleep apnoea)
  • Continuation of therapy
    • Time Frame: 3 months
    • Patients will be asked if they are going to continue therapy. Reasons for therapy termination shall be recorded

Participating in This Clinical Trial

Inclusion Criteria

  • Prescription of a Narval CC mandibular advancement device
  • Age ≥ 18 years
  • Ability to understand the study information and information on usage of personal data
  • Signed and dated informed consent

Exclusion Criteria

  • Patients with central sleep apnea (central AI > 5/hour)
  • Patients with loose teeth and severe parodontitis
  • Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Helmut Teschler, Prof, Principal Investigator, Institute of Digital Sleep Medicine
  • Overall Contact(s)
    • Oliver Munt, PhD, +491629056360, oliver.munt@resmed.de

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