Efficacy of Oral Appliance for Upper Airway Resistance Syndrome

Upper Airway Resistance Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02636621
• Other study ID #: SR94036
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2015
• Last updated: July 14, 2016
• Start date: October 2013
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: LUCIANA GODOY, MD
• Phone: 551121490155
• Email: lu_bmg[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Upper Airway Resistance Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Associação Fundo de Incentivo à Pesquisa (AFIP)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

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