Efficacy of Oral Appliance for Upper Airway Resistance Syndrome

NCT ID: NCT02636621

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brazilian Dental Appliance

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

Group Type: ACTIVE_COMPARATOR

Brazilian Dental Appliance

Intervention Type: 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.

Placebo

Oral device that does not change the volume of the airway

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Mandibular advancement device; Protective dental plate

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: lead

Responsible Party

Sonia Maria Guimaraes Pereira Togeiro Moura

Prof. Dra. Sonia Guimaraes Togeiro Moura

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Associação Fundo de Incentivo à Pesquisa (AFIP)

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

LUCIANA GODOY, MD

Role: CONTACT

lu_bmg@yahoo.com.br

551121490155

Facility Contacts

Sonia Togeiro, MD, PhD

Role: primary

sonia.togeiro@sono.org.br

Luciana Godoy

Role: backup

lu_bmg@yahoo.com.br

References

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.

Reference Type: DERIVED

PMID: 32686643 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29045745 (View on PubMed)

Other Identifiers

SR94036

Identifier Type: -

Identifier Source: org_study_id