Status:
UNKNOWN
Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Brief Summary
Sleep is an important factor that influences long-term quality of life with known health consequences. Obstructive sleep apnea, the most prevalent disease that disturbs sleep, is considered a public h...
Detailed Description
Design: observational, unicentric prospective. 50 patients / year will be included, for 3 years. The care protocol (evaluation and follow-up) of the multidisciplinary sleep unit will be followed. Demo...
Eligibility Criteria
Inclusion
- Diagnosis of Obstructive Sleep Apnea Syndrome
- opt for mandibular advancement device as 1st treatment alternative
- opt for mandibular advancement device due to intolerance to continuous positive airway pressure
Exclusion
- Patient with orthodontics, malocclusion and periodontal or temporomandibular joint disease who, after assessment by dentistry contraindicates it.
- Central Sleep apnea (more than 50% of central events in the baseline polygraph).
- Under 18 years old.
- Pregnancy
- Comorbidities that can potentially alter sleep architecture.
- Psychophysical inability to complete questionnaires.
- Not obtaining informed consent.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06169228
Start Date
January 1 2021
End Date
December 31 2024
Last Update
December 13 2023
Active Locations (1)
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1
Maria Fernanda Troncoso Acevedo
Madrid, Spain, 28004