Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy
ISRCTN | ISRCTN18174167 |
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DOI | https://doi.org/10.1186/ISRCTN18174167 |
Secondary identifying numbers | N/A |
- 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
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 |
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a.hoekema@kchir.umcg.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | Number of OSAHS patients successfully treated as a result of OA or CPAP therapy. |
Secondary outcome measures | 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]) |
Overall study start date | 01/09/2002 |
Completion date | 28/04/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 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
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
University of Groningen
Department of Oral and Maxillofacial Surgery
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Website | http://www.umcg.nl/azg/nl/english/azg/ |
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https://ror.org/03cv38k47 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/09/2013 | Yes | No |