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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732199
First Posted: August 11, 2008
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
The purpose for this research protocol was to examine the role of breathing control mechanisms that determine the development of sleep-disordered breathing in the elderly. This proposal focused on key factors that contribute to the control of ventilation in elderly adults during sleep. The investigators studied the age-specific changes in ventilatory control in older and young adults during NREM sleep.

Condition Intervention
Sleep Apnea Age Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determinants of Age-specific Breathing Instability During Sleep

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve [ Time Frame: 4-6 wks for each participant ]
    The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.

  • Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only [ Time Frame: 4-6 wks for each participant ]
    Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.


Secondary Outcome Measures:
  • Hypoxic Ventilatory Response [ Time Frame: 4-6 wks for each participant ]
    Hypoxic ventilatory response was calculated as the change in minuted ventilation for a change in oxygen saturation during each hypoxia trial.

  • Brief Hyperoxia Response [ Time Frame: 4-6 wks for each participant ]
    Brief hyperoxia response was the nadir minute ventilation achieved immediately upon exposure to brief hyperoxia expressed as a percent of eupneic minuted ventilation.


Enrollment: 92
Study Start Date: October 2008
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Determine the apneic threshold and carbon- dioxide reserve using noninvasive positive pressure ventilation during NREM sleep and determine the effect effect of episodic hypoxia on ventilatory long-term facilitation during NREM sleep in Young adults.
Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia
1) noninvasive hyperventilation to determine apneic threshold; 2) episodic hypoxia to determine ventilatory long term facilitation
Experimental: Arm 2
Determine the apneic threshold and carbon- dioxide reserve using noninvasive positive pressure ventilation during NREM sleep and determine the effect of episodic hypoxia on ventilatory long-term facilitation during NREM sleep in Older adults.
Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia
1) noninvasive hyperventilation to determine apneic threshold; 2) episodic hypoxia to determine ventilatory long term facilitation

Detailed Description:

Sleep apnea-hypopnea syndrome (SAS) is a relatively common disorder in the US population with significant adverse health consequences. Despite the high prevalence of SAS in elderly individuals, the underlying mechanisms have remained elusive. Specifically, the investigators do not know whether the high prevalence of sleep apnea in older adults is due to increased central breathing instability. This proposal focused on investigating age-specific differences in the susceptibility to central breathing instability in adults.

This project had the following specific objectives:

  • To determine age-specific changes in the hypocapnic apneic threshold during NREM sleep in elderly vs young individuals.
  • To determine age-specific changes in long-term facilitation during sleep in elderly versus young individuals.

Procedure: The investigators determined the susceptibility to central breathing instability by mechanically ventilating the subjects during NREM sleep using non-invasive pressure support ventilation. The investigators compared the hypocapnic apneic threshold in old (age>60 years) and young (age 18-50 years) individuals who were healthy. The investigators also measured the parameters over a continuum of age from 18 to 89 years.

- The investigators investigated whether there was a difference in the susceptibility to long term facilitation of ventilation between young and old healthy individuals in response to episodic hypoxia, while maintaining isocapnia.

Sleep apnea is very common in older Veterans and is associated with significant cardiovascular complications. Greater insight into the pathogenesis will have a positive impact on the health of Veterans suffering from this condition. This study furthers the understanding of the pathogenesis of breathing instability leading to sleep-disordered breathing during sleep. The investigators anticipate findings will provide a basis for new approaches to prevention and management of SAS in Veterans.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy older and young adults

Exclusion Criteria:

  • Pregnancy,
  • history of active coronary artery disease-including stable and unstable angina,
  • recent myocardial infarction,
  • history of congestive heart failure,
  • stroke,
  • excessive daytime sleepiness with Epworth Sleepiness Scale of >15
  • patient with OSA- (Obstructive sleep apnea) on therapy
  • depression,
  • schizophrenia,
  • untreated hypothyroidism,
  • diabetes on insulin,
  • seizure disorder,
  • intrinsic renal and liver disorders,
  • failure to give informed consent,
  • patients with evidence of pulmonary diseases based on history and abnormal pulmonary function testing, including obstructive (ratio of predicted forced expiratory volume to forced vital capacity, <80% predicted) or restrictive lung disorders (total lung capacity <80% predicted) with resting oxygen saturation of <96% and kyphoscoliosis (chest wall deformities)
  • patients on certain medications including, opiates derivatives, stimulants, antidepressants, tranquilizers, anti-psychotic agents, theophylline and other central nervous system altering medications
  • history of alcohol or recreational drug use will also serve as grounds for exclusion,
  • patients with body mass index (BMI) >34kg/m2
  • subjects with sleep apnea are already using continuous positive airway pressure for more than 7 days as therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732199


Locations
United States, Michigan
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Susmita Chowdhuri, MD John D. Dingell VA Medical Center, Detroit, MI
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00732199     History of Changes
Other Study ID Numbers: CDA-2-019-07F
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: December 14, 2016
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
apneic threshold
central apnea
intermittent hypoxia
aging
ventilation
chemoresponsiveness
carbon-dioxide reserve