Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients

Sleep Apnea, Obstructive Clinical Trial

— DAMOSA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06169228
• Other study ID #: PI19/00830
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	Maria Fernanda Troncoso Acevedo	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	home sleep apnea test	To evaluate the number of residual apneic breaths measured by home home sleep apnea test	3 years
Secondary	Obstructive sleep apnea severity	Evaluate the severity by home sleep apnea test	3 years
Secondary	questionnaire SF-12	multidimensional health related quality of life	3 years
Secondary	questionnaire EuroQoL	standardized non-disease specific instrument to describe and value health-related quality of life	3 years
Secondary	questionnaire iPAQ	International Physical Activity Questionnaire	3 years