Efficacy of Oral Appliance for Upper Airway Resistance Syndrome

NCT02636621 | Unknown

• 1 other identifier: SR94036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Airway Resistance Syndrome

Keywords

Fatigue; excessive daytime sleepiness; flow limitation

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Modified fatigue impact scale for Portuguese (MFIS- BR)

  From the baseline evaluation to one year after the treatment with oral appliance

Secondary Outcomes (15)

• Subjective excessive daytime sleepiness

  From the baseline evaluation to one year after the treatment with oral appliance

• Objective excessive daytime sleepiness

  From the baseline evaluation to one year after the treatment with oral appliance

• Mood - Anxiety

  From the baseline evaluation to one year after the treatment with oral appliance

• Mood - Depression

  From the baseline evaluation to one year after the treatment with oral appliance

• Sustained attention

  From the baseline evaluation to one year after the treatment with oral appliance

Study Arms (2)

Brazilian Dental Appliance

ACTIVE COMPARATOR

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

Device: Brazilian Dental Appliance

Placebo

PLACEBO COMPARATOR

Oral device that does not change the volume of the airway

Other: Placebo

Interventions

Brazilian Dental Appliance DEVICE

Brazilian Dental Appliance is an oral appliance worn only during sleep that supports the jaw in a forward position to help maintain an open upper airway.

Also known as: Mandibular advancement device

Brazilian Dental Appliance

Placebo OTHER

The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway.

Also known as: Protective dental plate

Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead

Study Sites (1)

Associação Fundo de Incentivo à Pesquisa (AFIP)

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

Related Publications (2)

• de Godoy LBM, Sousa KMM, Palombini LO, Poyares D, Dal-Fabbro C, Guimaraes TM, Tufik S, Togeiro SM. Long term oral appliance therapy decreases stress symptoms in patients with upper airway resistance syndrome. J Clin Sleep Med. 2020 Nov 15;16(11):1857-1862. doi: 10.5664/jcsm.8698.

  PMID: 32686643 DERIVED

• Godoy LBM, Palombini L, Poyares D, Dal-Fabbro C, Guimaraes TM, Klichouvicz PC, Tufik S, Togeiro SM. Long-Term Oral Appliance Therapy Improves Daytime Function and Mood in Upper Airway Resistance Syndrome Patients. Sleep. 2017 Dec 1;40(12). doi: 10.1093/sleep/zsx175.

  PMID: 29045745 DERIVED

MeSH Terms

Conditions

Fatigue; Disorders of Excessive Somnolence

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

LUCIANA GODOY, MD

CONTACT

551121490155; lu_bmg@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dra. Sonia Guimaraes Togeiro Moura

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 22, 2015
• Study Start: October 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

BR (1)