Status:
UNKNOWN
Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In this open prospective study 40 patients who received Mandibular Replacement Appliance (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be included. The patient's...
Eligibility Criteria
Inclusion
- Patients with documented OSAHS based on the following criteria:
- AHI \>= 5 Complaints of extreme daytime sleepiness with no other explanation and/or 2 or more of the following symptoms:
- choking or gasping during sleep
- recurrent awakenings from sleep
- un-refreshing sleep
- daytime fatigue
- impaired concentration
- Patients who received MRA as treatment for OSAHS
- AHI \>= 5 on at least 1 of the screening nights (patient does not wear MRA device)
- Male or female patients aged ≥ 18 years
- Patients with a co-operative attitude
- Written informed consent obtained
Exclusion
- Pregnant or lactating females or females at risk of pregnancy
- Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
- Cancer or any other chronic disease with poor prognosis and/or affecting patient status
- History of alcohol or drug abuse in the last 2 years
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- Patients who participate in another clinical study whose investigational plan is judged to interfere or affect any of the measures of this study
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01524510
Start Date
February 1 2011
Last Update
May 28 2015
Active Locations (1)
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1
UZA
Edegem, Antwerp, Belgium, 2650