Efficacy of Oral Appliance for Upper Airway Resistance Syndrome

July 14, 2016 updated by: Sonia Maria Guimaraes Pereira Togeiro Moura, Associação Fundo de Incentivo à Pesquisa

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04024-002
        • Recruiting
        • Associação Fundo de Incentivo à Pesquisa (AFIP)
        • Contact:
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Modified fatigue impact scale for Portuguese (MFIS- BR)
From the baseline evaluation to one year after the treatment with oral appliance

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective excessive daytime sleepiness
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Epworth sleepiness scale
From the baseline evaluation to one year after the treatment with oral appliance
Objective excessive daytime sleepiness
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Multiple Sleep Latency Test
From the baseline evaluation to one year after the treatment with oral appliance
Mood - Anxiety
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Beck inventories (BAI)
From the baseline evaluation to one year after the treatment with oral appliance
Mood - Depression
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Beck inventories (BDI)
From the baseline evaluation to one year after the treatment with oral appliance
Sustained attention
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Psychomotor Vigilance Test (PVT)
From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Memory
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Digit Symbol Substitution Test (DSST)
From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Learning strategies
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Rey Auditory-Verbal Learning Test (RAVLT)
From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Immediate and late memories
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Wechsler Memory Scale (WMS)
From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Processing speed ability
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Stroop Color Test
From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Visual attention
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Trail Making Test - TMT
From the baseline evaluation to one year after the treatment with oral appliance
Quality of sleep
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Pittsburgh Sleep Quality Index (PSQI)
From the baseline evaluation to one year after the treatment with oral appliance
Quality of life
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Functional Outcomes of Sleep Questionnaire (FOSQ)
From the baseline evaluation to one year after the treatment with oral appliance
Stress
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Teste de Lipp
From the baseline evaluation to one year after the treatment with oral appliance
Metabolism
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Blood analysis of metabolism
From the baseline evaluation to one year after the treatment with oral appliance
Autonomic nervous system analysis
Time Frame: From the baseline evaluation to one year after the treatment with oral appliance
Heart rate variability
From the baseline evaluation to one year after the treatment with oral appliance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Associação Fundo de Incentivo à Pesquisa

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SR94036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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