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

This study is currently recruiting participants.
Verified January 2013 by Associação Fundo de Incentivo à Pesquisa
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT01461486
First received: October 25, 2011
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Mild Obstructive Sleep Apnea Syndrome
Device: Continuous Positive Airway Pressure (CPAP)
Device: Oral Appliance (BRD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study

Resource links provided by NLM:


Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Primary Outcome Measures:
  • Excessive Daytime Sleepiness [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluations of fatigue. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ] [ Designated as safety issue: Yes ]
  • Evaluation of cognition. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ] [ Designated as safety issue: Yes ]
    Performance Vigilance Test (PVT)

  • Evaluation of depression. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ] [ Designated as safety issue: Yes ]
    Beck Depression Inventory - BDI

  • 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 ] [ Designated as safety issue: Yes ]
  • Evaluation of inflammation. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ] [ Designated as safety issue: Yes ]
    Blood analysis for inflammatory.

  • Evaluation of blood pressure. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ] [ Designated as safety issue: Yes ]
    Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.

  • Evaluation of sexual dysfunction. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ] [ Designated as safety issue: Yes ]
  • Evaluation of anxiety [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ] [ Designated as safety issue: Yes ]
    Beck Anxiety Inventory - BAI

  • Evaluation of metabolism [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ] [ Designated as safety issue: Yes ]
    Blood analysis for metabolism

  • Evaluation of hormonal alterations. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ] [ Designated as safety issue: Yes ]
    Blood analysis for hormonal alterations.

  • 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. ] [ Designated as safety issue: Yes ]
    Assessment of heart rate variability.

  • Evaluation of endothelial disfunction. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ] [ Designated as safety issue: Yes ]
    Assessment of endothelial disfunction.


Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Brazilian Dental Appliance (BRD).
No Intervention: Hygiene sleep care
Control group

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461486

Locations
Brazil
Associação Fundo de Incentivo à Pesquisa Recruiting
São Paulo, SP, Brazil, 04024-002
Contact: Lia Rita A Bittencourt, MD, PhD    55 11 21490155    lia.rita@unifesp.br   
Sub-Investigator: Cibele Dal-Fabbro, PhD         
Principal Investigator: Lia Rita A Bittencourt, MD, PhD         
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
  More Information

No publications provided

Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, Professor, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT01461486     History of Changes
Other Study ID Numbers: 1300/11
Study First Received: October 25, 2011
Last Updated: January 23, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
Continuous positive airway pressure
Oral appliance
mild Obstructive Sleep Apnea Syndrome

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014