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ID
Source
Brief title
Health condition
Obstructive Sleep Apnea
Sponsors and support
Intervention
Outcome measures
Primary outcome
Poly(somno)graphy 6 months after treatment (AHI, ODI 3%,..)
Secondary outcome
Quality of life: ESS and FOSQ-30
Patients’ complaints
BMI
Complications: temporomandibular dysfunction, dental problems,..
Background summary
A prospective cohort study of consecutive patients diagnosed with obstructive sleep apnea with an apnea-hypopnea index between 15-30. Drug-induced sleep endoscopy is performed before oral appliance treatment. Patients will be included into a positive- or negative- jaw thrust maneuver group. Both patients with a positive and negative chinlift will be included for oral appliance treatment. Primary outcome will be poly(somno)graphy (AHI) 6 months after treatment, compared to polo(somno)graphy (AHI) at diagnosis. Secondary outcomes will be quality of life measured by the ESS and FOSQ-30 questionnaire, patients’ complaints, BMI and complications.
Study objective
Drug-induced Sleep Endoscopy with cocomittant jaw thrust maneuver is a suitable predictor for succes of oral appliance treatment.
Study design
Start: 1 december 2019
Stop: 1 december 2020
Intervention
None
Inclusion criteria
- Patients of 18 years and older with obstructive sleep apnea confirmed by poly(somno)graphy
- Apnea-hypopnea index between 15 and 30
- BMI < 35
Exclusion criteria
- Dentition not suitable for OAT
- Other dental problems, e.g. temporomandibular dysfunction, micrognathia
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8425 |
| Other | MEC-U : W19.133 |