Efficacy of Oral Appliance for Upper Airway Resistance Syndrome

Associação Fundo de Incentivo à Pesquisa

Status: Unknown

Conditions: Upper Airway Resistance Syndrome

Treatments: Device: Brazilian Dental Appliance; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02636621

SR94036

Details and patient eligibility

About

Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness. There are few studies about UARS treatment and there is not any gold standard treatment for it yet.

Objective: Primary: To evaluate the efficacy of oral appliance on improving fatigue in patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic nervous system.

Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and Respiratory Disturbance Index - RDI - > 5 events per hour or more than 30% of total sleep time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue) of both genders, with body mass index (BMI) lower than 30Kg/m2 and between 25 to 50 years of age will be included. Subjects will be randomly distributed in OA group and placebo (without treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography, Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing, autonomic nervous system analysis (heart rate variability) and metabolic evaluation. Mean and standard deviation will be used for descriptive statistical analysis if normal distribution, and median and percentiles (25%, 75%) for variables not normally distributed. To compare treatment groups T test (parametric) and Mann Whitney (non parametric) will be used. For adjusted analysis, linear regression analysis will be used.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both genders
• Body mass index (BMI) ≤ 30Kg/m2
• Age from 25 to 50 years
• Clinical and polysomnographic diagnosis of Upper Airway Resistance Syndrome: Apnea/Hypopnea Index (AIH) ≤ 5 events/hour and Respiratory Disturbance Index (RDI) > 5 events/hour or > 30% of total sleep time with inspiratory flow limitation with excessive daytime somnolence or fatigue

Exclusion criteria

• Unsatisfactory dental condition or severe temporomandibular disfunction;
• Nasal obstruction;
• Alcohol abuse and excessive consumption of psychotropic drugs;
• Clinical, neurological or psychiatric diseases not treated
• Less than 6 hours of sleep

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Brazilian Dental Appliance

Active Comparator group

Description:

The device increases the volume of the airway by mandibular traction.

Treatment:

Device: Brazilian Dental Appliance

Placebo

Placebo Comparator group

Description:

Oral device that does not change the volume of the airway

Treatment:

Other: Placebo