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).
Prescription of any mandibular advancement device
Age ≥ 18 years
Ability to understand the study information and information on usage of personal data
Signed and dated informed consent
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
Eligible for recruitment are male and female patients of ≥ 18 years who have been diagnosed with OSA and who are not eligible for PAP treatment (no tolerance of PAP therapy, therapy refusal for any reason). Patients who have been prescribed an MAD as treatment for OSA. Patients will be followed in their clinical routine treatment pathway.
Cohort
Prospective
Not listed
Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months
Changes in the number of apnoeas (cessation of airflow) and hypopneas (reduced airflow) at baseline and at follow-up
Changes in sleep-related quality of life from baseline compared to 3 months follow-up
Changes in sleep-related quality of life assessed with the questionnaire FOSQ (Functional Outcomes of Sleep Questionnaire). The Functional Outcomes of Sleep questionnaire is a "self-report measure designed to assess the impact of disorders of excessive sleepiness on multiple activities of daily living" (Weaver 1997). It consists of 10 questions categorized as General Productivity, Social Outcome, Activity Level, Vigilance, Sexual Activity. The range of scores for any item is 1-4. The potential range of scores for the total score is 5-20, with 5 meaning bad sleep-related quality of life and 20 good sleep-related quality of life. The total score is being calculated by calculating the mean of the subscale scores and then multiply that mean by five. Missing or not applicable answers will not be added when calculating the mean subscale scores.
Changes in daytime sleepiness from baseline compared to 3 months follow-up
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). The ESS is self-reported measure to assess whether a person would be prone to fall asleep in typical daily situations. It consists of 8 questions that can be answered with 0 = would never fall asleep, 1 = slight probability of falling asleep, 2 = moderate probability of falling asleep, 3 = high probability of falling asleep. The scores will be added up to give a total ranging from 0 - 24 and indicating different levels of excessive daytime sleepiness (6-10 higher than normal; 11-12 mild; 13-15 moderate; 16-24 severe).
Changes in snoring from baseline compared to 3 months follow-up
Changes in snoring assessed with a snoring questionnaire (the Thornton Snoring Scale contains 5 questions about snoring as subjective patient's measure). The Thornton Snoring Scale consists of 5 questions that can be answered with 0 = never, 1 = infrequently, 2 = frequently, 3 = most of the time. The scores will be added and when the sum of all answers is higher than 5, a snoring problem is indicated.
Usage of the MAD (mandibular advancement device)
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.
