Efficacy of Oral Appliance for Upper Airway Resistance Syndrome

Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Upper Airway Resistance Syndrome
• Intervention / Treatment: Device: Brazilian Dental Appliance; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LUCIANA GODOY, MD; Phone Number: 551121490155; Email: lu_bmg@yahoo.com.br

Study Locations

• Brazil
  • São Paulo, Brazil, 04024-002
    • Recruiting
    • Associação Fundo de Incentivo à Pesquisa (AFIP)
    • Contact: Sonia Togeiro, MD, PhD; Email: sonia.togeiro@sono.org.br
    • Contact: Luciana Godoy; Email: lu_bmg@yahoo.com.br
    • Principal Investigator: Sonia G. Togeiro, MD, PhD
    • Sub-Investigator: Cibele Dal-Fabbro, PhD
    • Sub-Investigator: Luciana Palombini, PhD
    • Sub-Investigator: Luciana Godoy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brazilian Dental Appliance; The device increases the volume of the airway by mandibular traction.	Device: Brazilian Dental Appliance; 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.; Other Names: Mandibular advancement device
Placebo Comparator: Placebo; Oral device that does not change the volume of the airway	Other: Placebo; The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway.; Other Names: Protective dental plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Modified fatigue impact scale for Portuguese (MFIS- BR)	From the baseline evaluation to one year after the treatment with oral appliance

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective excessive daytime sleepiness	Epworth sleepiness scale	From the baseline evaluation to one year after the treatment with oral appliance
Objective excessive daytime sleepiness	Multiple Sleep Latency Test	From the baseline evaluation to one year after the treatment with oral appliance
Mood - Anxiety	Beck inventories (BAI)	From the baseline evaluation to one year after the treatment with oral appliance
Mood - Depression	Beck inventories (BDI)	From the baseline evaluation to one year after the treatment with oral appliance
Sustained attention	Psychomotor Vigilance Test (PVT)	From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Memory	Digit Symbol Substitution Test (DSST)	From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Learning strategies	Rey Auditory-Verbal Learning Test (RAVLT)	From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Immediate and late memories	Wechsler Memory Scale (WMS)	From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Processing speed ability	Stroop Color Test	From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Visual attention	Trail Making Test - TMT	From the baseline evaluation to one year after the treatment with oral appliance
Quality of sleep	Pittsburgh Sleep Quality Index (PSQI)	From the baseline evaluation to one year after the treatment with oral appliance
Quality of life	Functional Outcomes of Sleep Questionnaire (FOSQ)	From the baseline evaluation to one year after the treatment with oral appliance
Stress	Teste de Lipp	From the baseline evaluation to one year after the treatment with oral appliance
Metabolism	Blood analysis of metabolism	From the baseline evaluation to one year after the treatment with oral appliance
Autonomic nervous system analysis	Heart rate variability	From the baseline evaluation to one year after the treatment with oral appliance

Collaborators and Investigators

• Sponsor: Associação Fundo de Incentivo à Pesquisa

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Fatigue; excessive daytime sleepiness; flow limitation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: SR94036