Predicting the success of mandibular repositioning appliance therapy in obstructive sleep apnea

Predicting the success of mandibular repositioning appliance therapy in obstructive sleep apnea - PRESMO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48663

Enrollment

380

Registered

2018-12-11

Start date

2019-07-19

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSAS sleep apnea

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 18 years or older at time of inclusion • Established OSA (AHI of 5/hour or more on poly(somno)graphy) • Symptomatic OSA (ESS-score > 10)

Exclusion criteria

Exclusion criteria: • patients with dental status hindering the use of MRA such as less than 10 teeth per dental arch, periodontal and dental problems, severe temporomandibular disorders. Patients with dental implants are allowed to participate. • patients who cannot be properly instructed on the use of MRA, including patients with mental illness • presence of complete nasal obstruction • presence of a tumour in the upper airways • adenotonsillar hypertrophy grades 3 and 4 • body mass index > 40kg/m2 • presence of obesity hypoventilation syndrome • presence of any neuromuscular disorder • chronic obstructive lung disease (COPD) with documented hypercapnia • central sleep apnea component of > 50% of total AHI

Design outcomes

Primary

Measure	Time frame
effective treatment with MRA is described as a reduction in AHI of at least 50% combined with an AHI	—

Countries

Netherlands

Outcome results