Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients

NCT06169228 | Unknown

• 1 other identifier: PI19/00830
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Obstructive sleep apnea severity

  3 years

• questionnaire SF-12

  3 years

• questionnaire EuroQoL

  3 years

• questionnaire iPAQ

  3 years

Interventions

mandibular advancement DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Maria Fernanda Troncoso Acevedo

Madrid, 28004, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Mandibular Advancement

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Orthodontics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador principal

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: December 13, 2023
• Study Start: January 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)