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Determinants of Age Related Breathing Instability During Non-Rapid-Eye-Movement (NREM) Sleep

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00732199
First received: August 7, 2008
Last updated: April 10, 2017
Last verified: April 2017
Results First Received: December 14, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Sleep Apnea
Age
Intervention: Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia

  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
Participants were recruited by posting fliers at the sites approved by the Detroit VA clinical investigations committee and Wayne State IRB (institution review board). They completed a phone interview. If they qualified based on the inclusion/exclusion criteria they completed an informed consent. Dates 2008 to 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

Young adults, age 18-59yrs

hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation

Arm 2

Older adults, age >/=60 yrs

hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation


Participant Flow:   Overall Study
    Arm 1   Arm 2
STARTED   50   42 
COMPLETED   16   16 
NOT COMPLETED   34   26 
Withdrawal by Subject                25                18 
sleep apnea, inadequate signals/sleep                9                8 



  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.
We studied normal subjects. Subjects were assigned to two age categories, ‘young’ between 18 and 50 years, and ‘elderly' >55-60 years respectively. Participants with data available were included in the analysis Normal participants (controls) will have apnea hypopnea index, AHI<5/hour, respiratory events /hour of sleep

Reporting Groups
  Description
Health Young Adults

Health Young adults, age 18-50 yrs

hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation

Healthy Older Adults

Healthy Older adults, age >55-60yrs

hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation

Total Total of all reporting groups

Baseline Measures
   Health Young Adults   Healthy Older Adults   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   19   34 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 15   19   34 
   35.9  (9.9)   66.9  (5.4)   48.3  (17.6) 
Sex/Gender, Customized [1] [2] [3] 
[Units: Participants]
Count of Participants
     
Apneic Threshold & CO2 Reserve Analysis Population       
Participants Analyzed 
[Units: Participants]
 15   10   25 
Female      8  53.3%      6  60.0%      14  56.0% 
Male      7  46.7%      4  40.0%      11  44.0% 
LTF and Minute Ventilation Analysis Population       
Participants Analyzed 
[Units: Participants]
 15   14   29 
Female   NA [2]      8  57.1%   NA [3] 
Male   NA [2]      6  42.9%   NA [3] 
Hypoxic Ventilatory Response Analysis Population       
Participants Analyzed 
[Units: Participants]
 10   13   23 
Female      6  60.0%      7  53.8%      13  56.5% 
Male      4  40.0%      6  46.2%      10  43.5% 
Brief Hyperoxia Response Analysis Population       
Participants Analyzed 
[Units: Participants]
 9   10   19 
Female      3  33.3%      6  60.0%      9  47.4% 
Male      6  66.7%      4  40.0%      10  52.6% 
[1] Participants with data available were included in the analysis
[2] Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only
[3] Total not calculated because data are not available (NA) in one or more arms.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 15   19   34 
Female   8   12   20 
Male   7   7   14 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 15   19   34 
United States   15   19   34 
Body mass index 
[Units: Kg/m2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 15   19   34 
   26.4  (2.4)   27.3  (3.2)   26.8  (3.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve   [ Time Frame: 4-6 wks for each participant ]

2.  Primary:   Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only   [ Time Frame: 4-6 wks for each participant ]

3.  Secondary:   Hypoxic Ventilatory Response   [ Time Frame: 4-6 wks for each participant ]

4.  Secondary:   Brief Hyperoxia Response   [ Time Frame: 4-6 wks for each participant ]


  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
Participants who could not maintain stable sleep could not be included in the analyses. Participants also dropped out after the initial diagnostic sleep study as they did not want to continue the experimental arms.


  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: Susmita Chowdhuri
Organization: John D. Dingell VA Medical Center
phone: 313 576 1000 ext 3685
e-mail: susmita.chowdhuri@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00732199     History of Changes
Other Study ID Numbers: CDA-2-019-07F
Study First Received: August 7, 2008
Results First Received: December 14, 2016
Last Updated: April 10, 2017