Obstructive Sleep Apnea
Conditions
Interventions
For mild and moderate OSA, the treatment with a MAD is standard therapy. MAD is
an intra-oral prosthesis, which holds the mandible in a protrusive position.
Because of this position, more pharyngeal
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: + 18 years and older + Ability to speak, read, and write Dutch. + 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: - Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD. - Medication used/related to sleeping disorders. - Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome). - Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis) - Temporomandibular disorders (based on the function examination of the masticatory system). - Medical history of known causes of tiredness by day, or severe sleep disruption (insomnia, PLMS, Narcolepsy). - Known medical history of mental retardation, memory disorders, or psychiatric disorders. - Reversible morphological upper airway abnormalities (e.g. enlarged tonsils). - Inability to provide informed consent. - simultaneous use of other modalities to treat OSA. - Previous treatment with a MAD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: reduction of PSG parameters, in particular Apnoea Hypopnoea Index (AHI), Apnoea Index (AI), Hypopnoea Index (HI), Desaturation Index (DI), and sleep efficiency at baseline, 3 months, and 1 year. Addendum CBCT: Primary endpoint: minimum cross-sectional area (CSAmin); mandibular length (me-go). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: outcome of Quality of Life (QoL) questionnaires; the QoL is measured with questionnaires regarding general health (EQUOL), sleep health and daily functioning (AMCSQ, ESS, FOSQ), and functionality of the dentition and jaws (RDC/TMD and MFIQ) at baseline, 3, 6, 9 and 12 months. Compliance will also be evaluated for the time period of 3, 6, 9 and 12 months Addendum CBCT: Secondary endpoints are upper airway size: anterior-posterior (AP) and lateral (L) dimensions of the CSAmin, and the volume of the upper airway (V); upper airway shape: 2-D shape of the upper airway (AP/L); and 3-D shape of the upper airway (CSAmin / CSAavg); face width (tl-tr), anterior neck space area (ste-cr-ty-cer-me), and cervicomental angle (np-cer-me). | — |
Countries
Netherlands
Outcome results
None listed