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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

October 1, 2011

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1300/11

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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