Contact information
Type
Scientific
Primary contact
Dr A. Hoekema
ORCID ID
Contact details
Department of Oral and Maxillofacial Surgery
University Medical Center Groningen
University of Groningen
Hanzeplein 1
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3613840
a.hoekema@kchir.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)
Intervention
1. Oral Appliance (OA) therapy
2. Continuous Positive Airway Pressure (CPAP) therapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2002
Overall trial end date
28/04/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
102
Participant 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
Recruitment start date
01/09/2002
Recruitment end date
28/04/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Oral and Maxillofacial Surgery
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (The Netherlands)
Sponsor details
University of Groningen
Department of Oral and Maxillofacial Surgery
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23997361
Publication citations
-
Results
Doff MH, Hoekema A, Wijkstra PJ, van der Hoeven JH, Huddleston Slater JJ, de Bont LG, Stegenga B, Oral appliance versus continuous positive airway pressure in obstructive sleep apnea syndrome: a 2-year follow-up., Sleep, 2013, 36, 9, 1289-1296, doi: 10.5665/sleep.2948.