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Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy
ISRCTN ISRCTN18174167
DOI 10.1186/ISRCTN18174167
ClinicalTrials.gov identifier
EudraCT number
Public title Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)
Participants - 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
Participants - 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
Anticipated start date 01/09/2002
Anticipated end date 28/04/2005
Status of trial Completed
Patient information material
Target number of participants 102
Interventions 1. Oral Appliance (OA) therapy
2. Continuous Positive Airway Pressure (CPAP) therapy
Primary outcome measure(s) Number of OSAHS patients successfully treated as a result of OA or CPAP therapy.
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])
Sources of funding Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23997361
Contact name Dr  A.  Hoekema
  Address Department of Oral and Maxillofacial Surgery
University Medical Center Groningen
University of Groningen
Hanzeplein 1
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Tel +31 (0)50 3613840
  Fax +31 (0)50 3611136
  Email a.hoekema@kchir.umcg.nl
Sponsor University Medical Center Groningen (The Netherlands)
  Address University of Groningen
Department of Oral and Maxillofacial Surgery
Hanzeplein 1
  City/town Groningen
  Zip/Postcode 9713 GZ
  Country Netherlands
  Sponsor website: http://www.umcg.nl/azg/nl/english/azg/
Date applied 12/09/2005
Last edited 03/09/2013
Date ISRCTN assigned 12/09/2005
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