Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients (DAMOSA)

Impact of Treatment With Mandibular Advancement Device (MAD) on Sleep Quality in Patients With Obstructive Sleep Apnea (OSA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: mandibular advancement

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28004
    • Maria Fernanda Troncoso Acevedo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mandibular advancement device on sleep quality	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.	3 years
ambulatory circadian monitoring device	To evaluate improvement in sleep quality with mandibular advancement devices measured by fragmentation and stability of sleep by the circadian monitoring sensor.	3 years
home sleep apnea test	To evaluate the number of residual apneic breaths measured by home home sleep apnea test	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstructive sleep apnea severity	Evaluate the severity by home sleep apnea test	3 years
questionnaire SF-12	multidimensional health related quality of life	3 years
questionnaire EuroQoL	standardized non-disease specific instrument to describe and value health-related quality of life	3 years
questionnaire iPAQ	International Physical Activity Questionnaire	3 years

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PI19/00830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No