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
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesPrimary 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) studiedObstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)
Intervention1. Oral Appliance (OA) therapy
2. Continuous Positive Airway Pressure (CPAP) therapy
Intervention typeOther
Primary outcome measureNumber of OSAHS patients successfully treated as a result of OA or CPAP therapy.
Secondary outcome measuresImprovements 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 date01/09/2002
Completion date28/04/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants102
Key inclusion criteriaNewly 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 criteriaI. 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 enrolment01/09/2002
Date of final enrolment28/04/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Department of Oral and Maxillofacial Surgery
Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (The Netherlands)
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/
ROR logo "ROR" 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
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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