Clinical trial NCT02636621: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome
Official title: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Airway Resistance Syndrome
Keywords: Fatigue
excessive daytime sleepiness
flow limitation
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fatigue
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
Secondary outcomes:
measure: Subjective excessive daytime sleepiness
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Objective excessive daytime sleepiness
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Mood - Anxiety
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Mood - Depression
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Sustained attention
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Cognition - Memory
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Cognition - Learning strategies
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Cognition - Immediate and late memories
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Cognition - Processing speed ability
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Cognition - Visual attention
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Quality of sleep
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Quality of life
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Stress
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Metabolism
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
measure: Autonomic nervous system analysis
timeFrame: From the baseline evaluation to one year after the treatment with oral appliance
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Associação Fundo de Incentivo à Pesquisa (AFIP)
Study officials:
References:
citation: 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.
citation: 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.