Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy

Completed

• Conditions: Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS); Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN18174167
• Lead Sponsor: niversity Medical Center Groningen (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 102

Inclusion Criteria

Newly diagnosed OSAHS patients (over 20 years old) (i.e. criterion 1 and/or 2, plus criterion 3):
1. Excessive daytime sleepiness that is not better explained by other factors (Epworth Sleepiness Scale more than or equal to ten)
2. Two or more of the following symptoms that are not better explained by other factors:
a. choking or gasping during sleep
b. recurrent awakenings from sleep
c. unrefreshing sleep
d. daytime fatigue
e. impaired concentration
3. Overnight monitoring demonstrating an Apnea-Hypopnea Index (AHI) more than five

Exclusion Criteria

I.
1. Patients previously treated by:
a. CPAP
b. OA
c. uvulopalatopharyngoplasty
2. Morphological upper airway abnormalities requiring treatment:
a. compromised nasal passage
b. enlarged tonsils/ adenoids
c. soft tissue- or craniofacial abnormalities in upper airway
d. upper airway neoplasm
3. Endocrine dysfunction:
a. acromegaly
b. hypothyrodism
4. Co-morbidity:
a. daytime respiratory insufficiency
b. severe Chronic Obstructive Pulmonary Disease (COPD) (Forced Expriatory Volume in one second (FEV1)/Vital Capacity (VC) less than 40%)
c. left ventricular failure
d. severe daytime cardiac arrhythmias
5. Psychological condition precluding informed consent:
a. psychiatric diseases (eg depression, schizofrenia)
b. mental retardation

II. Dental exclusion criteria:
1. Severe periodontal disease or dental decay
2. 'Active' temporomandibular joint disease (including severe bruxism)
3. Restrictions in mandibular opening or protrusion capacity:
a. mouth opening less than 25 mm
b. maximal protrusion mandible less than 5 mm
4. Partial or complete edentulism:
a. Less than eight teeth in upper or lower jaw

III. Patients declining written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified