Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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mandibular advancement

The multidisciplinary sleep unit assessment and follow-up protocol will be followed for this group of patients based on the Spanish Clinical Practice Guideline of the Spanish Sleep Society (SES) on the use of mandibular advancement devices in the treatment of patients with obstructive sleep apnea

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Maria Fernanda Troncoso

Investigador principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maria Fernanda Troncoso Acevedo

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI19/00830

Identifier Type: -

Identifier Source: org_study_id