Management of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22799

Enrollment

102

Registered

2005-08-02

Start date

2002-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS).

Interventions

1. Oral Appliance (OA) therapy

2. Continuous Positive Airway Pressure (CPAP) therapy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed OSAHS patients (i.e. criterion A and/or B, plus criterion C): a. Excessive daytime sleepiness that is not better explained by other factors (Epworth Sleepiness Scale ¡Ý 10). b. Two or more of the following symptoms that are not better explained by other factors; -choking or gasping during sleep -recurrent awakenings from sleep -unrefreshing sleep -daytime fatigue -impaired concentration c. Overnight monitoring demonstrating an Apnea-Hypopnea Index (AHI) > 5. 2. Patients older than 20 years of age

Exclusion criteria

Exclusion criteria: I. Exclusioncriteria 1. Patients previously treated by: -CPAP -OA -uvulopalatopharyngoplasty; 2. Morphological upper airway abnormalities requiring treatment: -compromised nasal passage -enlarged tonsils/ adenoids -soft tissue- or craniofacial abnormalities in upper airway - upper airway neoplasm; 3. Endocrine dysfunction: -acromegaly -hypothyrodism; 4. Co-morbidity: -daytime respiratory insufficiency -severe COPD (FEV1/VC <40%) -left ventricular failure -severe daytime cardiac arrhythmias; 5. Psychological condition precluding informed consent: -psychiatric diseases (eg depression, schizofrenia) -mental retardation; II. Dental exclusioncriteria 6. Severe periodontal disease or dental decay; 7. ¡°Active¡± temporomandibular joint disease (including severe bruxism); 8. Restrictions in mandibular opening- or protrusion capacity: -mouth opening <25 mm -maximal protrusion mandible <5 mm 9. Partial or complete edentulism: -<8 teeth in upper- or lower jaw; III. Patients declining written informe d consent.

Design outcomes

Primary

Measure	Time frame
Number of OSAHS patients successfully treated as a result of OA or CPAP therapy.	—

Secondary

Measure	Time frame
Improvements in: 1. polysomnographic indices; 2. neurobehavioral outcomes (e.g. SF-36, FOSQ, ESS, HADS); 3. simulated driving performance; 4. cardiovascular outcomes (e.g. BNP); 5. sexual dysfunction (e.g. GRISS).	—

Contacts

Public ContactA. Hoekema

University Medical Center Groningen (UMCG), Department of Oral and Maxillofacial Surgery, P.O. Box 30.001

a.hoekema@kchir.umcg.nl+31 (0)50 3613840

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)