Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea (OSAS)

November 11, 2019 updated by: Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa

Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study

Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.

Study Overview

Status

Status

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

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 (Actual)

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.
79

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 Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04024-002
        • Associação Fundo de Incentivo à Pesquisa

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both genders;
  • body mass index lower than 35Kg/m2;
  • age between 18 and 65 years old;
  • polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm.

Exclusion Criteria:

  • Unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content);
  • temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp);
  • excessive use of alcohol and psychoactive drugs;
  • clinical, neurological or psychiatric decompensated diseases;
  • others sleep diseases and previous obstructive sleep apnea treatment.

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: Continuous Positive Airway Pressure
Intervention group
Device: Continuous Positive Airway Pressure (CPAP)
The device is a flow generator used to open the airway during sleep.
Other Names:
  • Resmed (trademark). Autoset Vantage - fixed pressure.
Active Comparator: Oral Appliance (BRD)
Intervention group
Device: Oral Appliance (BRD)
The device increases the volume of the airway by mandibular traction.
Other Names:
  • Brazilian Dental Appliance (BRD).
No Intervention: Hygiene sleep care
Control group

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
Time Frame
Excessive Daytime Sleepiness
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.

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
Evaluations of fatigue.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of cognition.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Performance Vigilance Test (PVT)
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of depression.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Beck Depression Inventory - BDI
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of quality of life.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of inflammation.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Blood analysis for inflammatory.
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of blood pressure.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of sexual dysfunction.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of anxiety
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Beck Anxiety Inventory - BAI
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of metabolism
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Blood analysis for metabolism
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of hormonal alterations.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Blood analysis for hormonal alterations.
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of heart rate variability
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Assessment of heart rate variability.
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of endothelial disfunction.
Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Assessment of endothelial disfunction.
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2011

Primary Completion (Actual)

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.
November 1, 2019

Study Completion (Actual)

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.
November 1, 2019

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).
October 25, 2011

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.
October 27, 2011

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.
October 28, 2011

Study Record Updates

Last Update Posted (Actual)

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.
November 13, 2019

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.
November 11, 2019

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.
November 1, 2019

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.
  • 1300/11

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