NCT06169228

Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-30
• Completion: 2024-12-31
• First posted: 2023-12-13
• Last updated: 2023-12-13

Locations

1 site across 1 country: Spain