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

Primary Purpose

Mild Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Oral Appliance (BRD)
Sponsored by
Associação Fundo de Incentivo à Pesquisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Obstructive Sleep Apnea Syndrome focused on measuring Continuous positive airway pressure, Oral appliance, mild Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Associação Fundo de Incentivo à Pesquisa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Continuous Positive Airway Pressure

Oral Appliance (BRD)

Hygiene sleep care

Arm Description

Intervention group

Intervention group

Control group

Outcomes

Primary Outcome Measures

Excessive Daytime Sleepiness

Secondary Outcome Measures

Evaluations of fatigue.
Evaluation of cognition.
Performance Vigilance Test (PVT)
Evaluation of depression.
Beck Depression Inventory - BDI
Evaluation of quality of life.
Evaluation of inflammation.
Blood analysis for inflammatory.
Evaluation of blood pressure.
Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.
Evaluation of sexual dysfunction.
Evaluation of anxiety
Beck Anxiety Inventory - BAI
Evaluation of metabolism
Blood analysis for metabolism
Evaluation of hormonal alterations.
Blood analysis for hormonal alterations.
Evaluation of heart rate variability
Assessment of heart rate variability.
Evaluation of endothelial disfunction.
Assessment of endothelial disfunction.

Full Information

First Posted
October 25, 2011
Last Updated
November 11, 2019
Sponsor
Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01461486
Brief Title
Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
Acronym
OSAS
Official Title
Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Obstructive Sleep Apnea Syndrome
Keywords
Continuous positive airway pressure, Oral appliance, mild Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Positive Airway Pressure
Arm Type
Active Comparator
Arm Description
Intervention group
Arm Title
Oral Appliance (BRD)
Arm Type
Active Comparator
Arm Description
Intervention group
Arm Title
Hygiene sleep care
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Other Intervention Name(s)
Resmed (trademark). Autoset Vantage - fixed pressure.
Intervention Description
The device is a flow generator used to open the airway during sleep.
Intervention Type
Device
Intervention Name(s)
Oral Appliance (BRD)
Other Intervention Name(s)
Brazilian Dental Appliance (BRD).
Intervention Description
The device increases the volume of the airway by mandibular traction.
Primary Outcome Measure Information:
Title
Excessive Daytime Sleepiness
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary Outcome Measure Information:
Title
Evaluations of fatigue.
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Title
Evaluation of cognition.
Description
Performance Vigilance Test (PVT)
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Title
Evaluation of depression.
Description
Beck Depression Inventory - BDI
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Title
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
Title
Evaluation of inflammation.
Description
Blood analysis for inflammatory.
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Title
Evaluation of blood pressure.
Description
Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Title
Evaluation of sexual dysfunction.
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Title
Evaluation of anxiety
Description
Beck Anxiety Inventory - BAI
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Title
Evaluation of metabolism
Description
Blood analysis for metabolism
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Title
Evaluation of hormonal alterations.
Description
Blood analysis for hormonal alterations.
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Title
Evaluation of heart rate variability
Description
Assessment of heart rate variability.
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Title
Evaluation of endothelial disfunction.
Description
Assessment of endothelial disfunction.
Time Frame
From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Associação Fundo de Incentivo à Pesquisa
City
São Paulo
State/Province
SP
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32964829
Citation
Guimaraes TM, Poyares D, Oliveira E Silva L, Luz G, Coelho G, Dal Fabbro C, Tufik S, Bittencourt L. The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment. J Clin Sleep Med. 2021 Feb 1;17(2):149-158. doi: 10.5664/jcsm.8822.
Results Reference
derived
PubMed Identifier
30077018
Citation
M Guimaraes T, Bittencourt L, P Luz G, O Silva L, Burke P, Coelho G, Milani A, Badke L, Togeiro S, Tufik S, Poyares D. Association between nondipping pattern and EndoPAT signal in patients with mild obstructive sleep apnea. Sleep Med. 2018 Nov;51:9-14. doi: 10.1016/j.sleep.2018.05.041. Epub 2018 Jun 27.
Results Reference
derived

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

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