Respiratory and Autonomic Plasticity Following Intermittent Hypoxia (RAP-IH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00860743
First received: March 10, 2009
Last updated: February 23, 2015
Last verified: February 2015
Results First Received: December 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Sleep Apnea Syndromes
Intervention: Drug: Antioxidant cocktail

  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
This study recruited participants between the years 2009-2013. The study was completed at the John D. Dingell VA Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
  1. Participants did not meet the inclusion criteria. This was typically due to EKG abnormalities or high blood pressure.
  2. Participants completed a "practice run" following consent to introduce them to equipment and procedures. Some participants choose not to continue following the practice run usually because of discomfort.

Reporting Groups
  Description
OSA/Healthy - Males/Females - Wake/Sleep We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
Arm 2

We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.

Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.


Participant Flow:   Overall Study
    OSA/Healthy - Males/Females - Wake/Sleep     Arm 2  
STARTED     40     23  
COMPLETED     37     23  
NOT COMPLETED     3     0  
Withdrawal by Subject                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Overall 40 participants were enrolled in Aim 1. One OSA male and two healthy male participants were enrolled but withdrew from the study. Thus, the total number that completed Aim 1 was 37 participants.

Reporting Groups
  Description
Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
Aim 2 - OSA - Hypoxia - Antioxidant/Placebo

We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.

Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.

Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Total Total of all reporting groups

Baseline Measures
    Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham     Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham     Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham     Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham     Aim 2 - OSA - Hypoxia - Antioxidant/Placebo     Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo     Total  
Number of Participants  
[units: participants]
  11     7     12     10     13     10     63  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  24.8  ± 3.1     26.6  ± 5.9     25.2  ± 4.0     24.8  ± 4.1     31.2  ± 6.2     29.1  ± 5.1     26.6  ± 5.4  
Gender  
[units: participants]
             
Female     0     7     0     10     0     0     17  
Male     11     0     12     0     13     10     46  
Ethnicity (NIH/OMB)  
[units: participants]
             
Hispanic or Latino     0     0     0     0     0     1     1  
Not Hispanic or Latino     11     7     12     10     13     9     62  
Unknown or Not Reported     0     0     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
             
American Indian or Alaska Native     0     0     0     0     0     0     0  
Asian     0     0     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0  
Black or African American     5     5     5     5     4     6     30  
White     6     2     7     5     9     4     33  
More than one race     0     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
             
United States     11     7     12     10     13     10     63  



  Outcome Measures
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1.  Primary:   Ventilation (Aim 1)   [ Time Frame: Within the same experimental session ]

2.  Primary:   Heart Rate Variability (Aim 2)   [ Time Frame: Within the same experimental session ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The primary limitation of this trial was the number of participants that required screening to recruit the participants that met the inclusion criteria for the study. However, once the participants were recruited few withdrew.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jason H. Mateika
Organization: Wayne State University and John D. Dingell VA Medical Center
phone: 313-576-4481
e-mail: jmateika@med.wayne.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00860743     History of Changes
Other Study ID Numbers: PULM-014-08F, GRANT00507547
Study First Received: March 10, 2009
Results First Received: December 10, 2014
Last Updated: February 23, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration