Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients
- Conditions
- Sleep Apnea, Obstructive
- Registration Number
- NCT06169228
- Lead Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- 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 health problem. Treatment with continuous positive airway pressure is cost effective and reverses the clinical consequences but there is a percentage of patients who do not tolerate it or leave it without treatment and with potential future health complications. Mandibular advancement device can be a valid and well tolerated alternative, it is known that it reduces apnea-hypopnea index, but its effect on the improvement of sleep quality is evaluated by polysomnography that interferes with the quality of sleep. There is an ambulatory monitoring device for sleep quality and circadian rhythms, which can register prolonged periods of time, under natural conditions and at a lower cost than a polysomnography. This pilot project assesses whether mandibular advancement device is an effective and well tolerated alternative in the treatment of obstructive sleep apnea to improve the quality of life and sleep in the medium and long term.
- 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. Demographic and anthropometric data will be collected. The dental status of the temporo-mandibular joint will be assessed. Radiological records, home respiratory polygraphy, ambulatory monitoring device for 7 days , quality of life questionnaires before and after treatment.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mandibular advancement device on sleep quality 3 years Tolerability and efficacy of treatment with a mandibular advancement device (MAD) on sleep quality in patients with Obstructive Sleep Apnea (OSA) measured by the ambulatory circadian monitoring device.
ambulatory circadian monitoring device 3 years To evaluate improvement in sleep quality with mandibular advancement devices measured by fragmentation and stability of sleep by the circadian monitoring sensor.
home sleep apnea test 3 years To evaluate the number of residual apneic breaths measured by home home sleep apnea test
- Secondary Outcome Measures
Name Time Method questionnaire EuroQoL 3 years standardized non-disease specific instrument to describe and value health-related quality of life
questionnaire iPAQ 3 years International Physical Activity Questionnaire
Obstructive sleep apnea severity 3 years Evaluate the severity by home sleep apnea test
questionnaire SF-12 3 years multidimensional health related quality of life
Trial Locations
- Locations (1)
Maria Fernanda Troncoso Acevedo
🇪🇸Madrid, Spain