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

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

Sponsors

Lead sponsor: ResMed

Source ResMed
Brief Summary

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).

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.

Overall Status Recruiting
Start Date May 27, 2020
Completion Date March 31, 2022
Primary Completion Date December 31, 2021
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months 3 months
Secondary Outcome
Measure Time Frame
Changes in sleep-related quality of life from baseline compared to 3 months follow-up 3 months
Changes in daytime sleepiness from baseline compared to 3 months follow-up 3 months
Changes in snoring from baseline compared to 3 months follow-up 3 months
Usage of the Narval MAD (mandibular advancement device) 3 months
Side effects with use of the Narval MAD (mandibular advancement device) 3 months
Document comorbidities of enrolled patients 3 months
Remuneration of a Narval MAD 3 months
Satisfaction with therapy 3 months
Document sleep disorders of enrolled patients 3 months
Continuation of therapy 3 months
Enrollment 250
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Christoph Schoebel, Prof Principal Investigator Ruhrlandklinik Essen
Overall Contact

Last name: Oliver Munt, PhD

Phone: +491629056360

Email: [email protected]

Location
facility status contact contact_backup Ruhrlandklinik Essen Christoph Schoebel, Prof +49200143301 [email protected]
Location Countries

Germany

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov