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Management of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy.


- candidate number1167
- NTR NumberNTR106
- ISRCTNISRCTN18174167
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-aug-2005
- Date Registered NTR2-aug-2005
- Secondary IDsN/A 
- Public TitleManagement of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy.
- Scientific TitleManagement of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy.
- ACRONYMN/A
- hypothesisPrimary 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 hypothesized that OA and CPAP therapy are equivalent with respect to the successful management of OSAHS. Secondary aims of the randomised trial are to elucidate:
- prognostic variables of the therapeutic efficacy of OA and CPAP therapy, respectively.
- co-morbidity of OA therapy.
- the therapeutic effect of OA and CPAP therapy, respectively, on OSAHS related co-morbidity (neurobehavioral dysfunction, deviant driving performance, cardiovascular disease, sexual dysfunction).
- Healt Condition(s) or Problem(s) studiedObstructive sleep apnea syndrome
- Inclusion criteria1. Newly diagnosed OSAHS patients (i.e. criterion A and/or B, plus criterion C):
a. Excessive daytime sleepiness that is not better explained by other factors (Epworth Sleepiness Scale ¡İ 10).
b. Two or more of the following symptoms that are not better explained by other factors;
-choking or gasping during sleep
-recurrent awakenings from sleep
-unrefreshing sleep
-daytime fatigue
-impaired concentration
c. Overnight monitoring demonstrating an Apnea-Hypopnea Index (AHI) > 5.
2. Patients older than 20 years of age
- Exclusion criteriaI. Exclusioncriteria

1. Patients previously treated by:
-CPAP
-OA
-uvulopalatopharyngoplasty;
2. Morphological upper airway abnormalities requiring treatment:
-compromised nasal passage
-enlarged tonsils/ adenoids
-soft tissue- or craniofacial abnormalities in upper airway
- upper airway neoplasm;
3. Endocrine dysfunction:
-acromegaly
-hypothyrodism;
4. Co-morbidity:
-daytime respiratory insufficiency
-severe COPD (FEV1/VC <40%)
-left ventricular failure
-severe daytime cardiac arrhythmias;
5. Psychological condition precluding informed consent:
-psychiatric diseases (eg depression, schizofrenia)
-mental retardation;

II. Dental exclusioncriteria

6. Severe periodontal disease or dental decay;
7. ¡°Active¡± temporomandibular joint disease (including severe bruxism);
8. Restrictions in mandibular opening- or protrusion capacity:
-mouth opening <25 mm
-maximal protrusion mandible <5 mm
9. Partial or complete edentulism:
-<8 teeth in upper- or lower jaw;

III. Patients declining written informe
d consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2002
- planned closingdate28-apr-2005
- Target number of participants102
- Interventions1. Oral Appliance (OA) therapy;
2. Continuous Positive Airway Pressure (CPAP) therapy.
- Primary outcomeNumber of OSAHS patients successfully treated as a result of OA or CPAP therapy.
- Secondary outcomeImprovements in:
1. polysomnographic indices;
2. neurobehavioral outcomes (e.g. SF-36, FOSQ, ESS, HADS);
3. simulated driving performance;
4. cardiovascular outcomes (e.g. BNP);
5. sexual dysfunction (e.g. GRISS).
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. A. Hoekema
- CONTACT for SCIENTIFIC QUERIESDrs. A. Hoekema
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Oral and Maxillofacial Surgery
- Funding
(Source(s) of Monetary or Material Support)
the Netherlands Organisation for Health Research and Development
- Publications1. Sleep Breath. 2006 Jun;10(2):102-3.


2. Hoekema A, Stegenga B, de Bont LGM. Efficacy and Co-Morbidity of Oral Appliances in the Treatment of Obstructive Sleep Apnea-Hypopnea: a Systematic Review. Crit Rev Oral Biol Med 2004;15 (3):137-155.
- Brief summaryThe Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is common sleep disorder with life threatening sequelae. Continuous Positive Airway Pressure (CPAP) therapy ¡± is currently regarded as the treatment standard for OSAHS. Besides CPAP, dental devices known as Oral Appliances (OA¡¯s) have been of significance in the treatment of this sleep related breathing disorder. However, the evidence-base with respect to the efficacy and co-morbidity of OA therapy in the management of OSAHS is still insufficient. Primary aim of the present randomised trial is to elucidate the efficacy of, respectively, OA and CPAP therapy in the management of OSAHS. In order to do so eligible OSAHS patients are randomised for either OA or CPAP therapy and followed for a two year period. On the basis of the study results we hope to elucidate the therapeutic efficacy and the specific indication for, respectively, OA and CPAP therapy in the management of OSAHS. A secondary aim is to find possible prognostic variables for the therapeutic efficacy of OA and CPAP therapy. In addition, we hope to elucidate the co-morbidity of Oral Appliance therapy and explore the therapeutic effect of OA and CPAP therapy on OSAHS related co-morbidity (neurobehavioral dysfunction, deviant driving performance, cardiovascular disease and sexual dysfunction).
- Main changes (audit trail)
- RECORD5-aug-2005 - 9-jul-2008


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