Slaapstoornissen, slaapapneu OSA OSAS
Conditions
Interventions
This study focuses on preference of OSA patients for one or another MAD type by
comparing two different types of MADs in a randomized crossover design. The
first type is the Narval CC® (ResMed, Lyon
Sponsors
Universiteit van Amsterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 18 years or older; • Sufficient understanding of Dutch language in speaking, reading, and writing; • Ability to follow-up; • Ability to use a computer with internet connection for online questionnaires; • Diagnosis with symptomatic mild or moderate OSA (5
Exclusion criteria
Exclusion criteria: • Reversible morphological upper airway abnormalities (e.g. enlarged tonsils); • Previous treatment with an MAD; • Inability to provide informed consent; • Simultaneous use of other modalities to treat OSA; • Known medical history of mental retardation, memory disorders, or psychiatric disorders; • Evidence of respiratory/sleep disorders other than OSA (e.g., central sleep apnea (CSA)); • Medication usage that has an effect on sleep; • Untreated periodontal problems, dental pain, and a lack of retention possibilities for both MADs; • Severe temporomandibular disorders (based on the function examination of the masticatory system).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to compare the Narval CC® and the SomnoDent Flex® in a short-term and long-term follow-up. The primary outcome measures in the short-term and long-term follow-up are: Short-term follow-up: Primary outcome measure: 1. Preferred MAD: outcome based on a questionnaire on preference. Long-term follow-up: Primary outcome measure: 1. Mean disease alleviation: the product of sleep-time adjusted adherence (subjective oral appliance (OA) use/total sleep time, expressed in percentage) with therapeutic MAD efficacy (AHI baseline minus AHI with OA applied, expressed in percentage), divided by 100. | — |
Secondary
| Measure | Time frame |
|---|---|
| The aim of this study is to compare the Narval CC® and the SomnoDent Flex® in a short-term and long-term follow-up. The secondary outcome measures in the short-term and long-term follow-up are: Short-term follow-up: Secondary outcome measures: 1. Adherence: self-reported number of hours of wearing the MAD per total sleep time, in hours, *100%. 2. Therapy success: the number of patients with an apnea-hypopnea index (AHI) of | — |
Countries
Netherlands
Outcome results
None listed