Condition category
Nervous System Diseases
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
03/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

ZonMw

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

  1. 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.

Additional files

Editorial Notes