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

ISRCTN	ISRCTN18174167
DOI	https://doi.org/10.1186/ISRCTN18174167
Protocol serial number	N/A
Sponsor	University Medical Center Groningen (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 03/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A. Hoekema
Scientific

Department of Oral and Maxillofacial Surgery
University Medical Center Groningen
University of Groningen
Hanzeplein 1
P.O. Box 30001
Groningen
9700 RB
Netherlands

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Primary aim of the randomised trial is to elucidate the efficacy of, respectively, Oral Appliance (OA) and Continuous Positive Airway Pressure (CPAP) therapy in the management of the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). It is hypothesised that OA and CPAP therapy are equivalent with respect to the successful management of OSAHS. Secondary aims of the randomised trial are to elucidate: 1. Prognostic variables of the therapeutic efficacy of OA and CPAP therapy, respectively. 2. Co-morbidity of OA therapy. 3. The therapeutic effect of OA and CPAP therapy, respectively, on OSAHS related co-morbidity (neurobehavioral dysfunction, deviant driving performance, cardiovascular disease, sexual dysfunction). Further information in: http://www.ncbi.nlm.nih.gov/pubmed/15187032
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)
Intervention	1. Oral Appliance (OA) therapy 2. Continuous Positive Airway Pressure (CPAP) therapy
Intervention type	Other
Primary outcome measure(s)	Number of OSAHS patients successfully treated as a result of OA or CPAP therapy.
Key secondary outcome measure(s)	Improvements in: 1. Polysomnographic indices 2. Neurobehavioral outcomes (e.g. Short Form health survey [SF-36], Functional Outcomes of Sleep Questionnaire [FOSQ], Epworth Sleepiness Scale [ESS], Hospital Anxiety and Depression Scale [HADS]) 3. Simulated driving performance 4. Cardiovascular outcomes (e.g. B-type Natriuretic Peptide [BNP]) 5. Sexual dysfunction (e.g. Golombok-Rust Inventory of Sexual Satisfaction [GRISS])
Completion date	28/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	102
Key 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
Key exclusion criteria	I. Exclusion criteria: 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
Date of first enrolment	01/09/2002
Date of final enrolment	28/04/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Oral and Maxillofacial Surgery

Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No