Clinical trial NCT06169228: Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients
Official title: Impact of Treatment With Mandibular Advancement Device (MAD) on Sleep Quality in Patients With Obstructive Sleep Apnea (OSA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who come to the Multidisciplinary sleep unit of the Fundación Jiménez Díaz with suspicion of Obstructive sleep apnea and who present an Apnea Hypopnea Index greater than five

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: mandibular advancement device on sleep quality
timeFrame: 3 years
measure: ambulatory circadian monitoring device
timeFrame: 3 years
measure: home sleep apnea test
timeFrame: 3 years
Secondary outcomes:
measure: Obstructive sleep apnea severity
timeFrame: 3 years
measure: questionnaire SF-12
timeFrame: 3 years
measure: questionnaire EuroQoL
timeFrame: 3 years
measure: questionnaire iPAQ
timeFrame: 3 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Maria Fernanda Troncoso Acevedo
Study officials:
References: