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Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT01289392
First received: January 31, 2011
Last updated: April 25, 2013
Last verified: March 2013
History of Changes
Results First Received: January 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Interventions: Device: Continuous Positive Airway Pressure (CPAP)
Device: Oral Appliance (OA)
Behavioral: Physical Exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
sleep disorder clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Continuous Positive Airway Pressure (CPAP)

CPAP is the gold standard treatment

Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise
Oral Appliance

Alternative treatment for obstructive sleep apnea patients

Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise
Physical Exercise

Aerobic and resistance physical exercises

Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months

Participant Flow:   Overall Study
    Continuous Positive Airway Pressure (CPAP)     Oral Appliance     Physical Exercise  
STARTED     9     9     7  
COMPLETED     9     9     7  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Continuous Positive Airway Pressure (CPAP)

CPAP is the gold standard treatment

Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise
Oral Appliance

Alternative treatment for obstructive sleep apnea patients

Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise
Physical Exercise

Aerobic and resistance physical exercises

Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months
Total Total of all reporting groups

Baseline Measures
    Continuous Positive Airway Pressure (CPAP)     Oral Appliance     Physical Exercise     Total  
Number of Participants  
[units: participants]
 		  9     9     7     25  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     9     9     7     25  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  38.62  ± 8.15     42.33  ± 6.20     42.28  ± 8.28     41.10  ± 7.27  
Gender  
[units: participants]
 		       
Female     0     0     0     0  
Male     9     9     7     25  
Region of Enrollment  
[units: participants]
 		       
Brazil     9     9     7     25  



  Outcome Measures

1.  Primary:   Sleep Apnea   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Primary:   Objective Sleep Parameters   [ Time Frame: 6 months after the basal evaluation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Inflammatory Markers   [ Time Frame: 6 months after the basal evaluation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr Teresa Cristina Barros Schutz
Organization: Associação Fundo de Incentivo à Pesquisa
phone: 55-21-99868033
e-mail: schutzferraz@gmail.com


No publications provided


Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT01289392     History of Changes
Other Study ID Numbers: CEP 0352/09
Study First Received: January 31, 2011
Results First Received: January 28, 2013
Last Updated: April 25, 2013
Health Authority: Brazil: Comissão Nacional de Ética em Pesquisa