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

NCT00732199 | Completed Results DMC

• 1 other identifier: CDA-2-019-07F
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea; Age

Keywords

apneic threshold; central apnea; intermittent hypoxia; aging; ventilation; chemoresponsiveness; carbon-dioxide reserve

Outcome Measures

Primary Outcomes (2)

• Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve

  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.

  4-6 wks for each participant

• Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only

  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.

  4-6 wks for each participant

Secondary Outcomes (2)

• Hypoxic Ventilatory Response

  4-6 wks for each participant

• Brief Hyperoxia Response

  4-6 wks for each participant

Study Arms (2)

Arm 1

OTHER

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

Arm 2

EXPERIMENTAL

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

Interventions

1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia OTHER

1\) noninvasive hyperventilation to determine apneic threshold; 2) episodic hypoxia to determine ventilatory long term facilitation

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy older and young adults

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• Chowdhuri S, Pranathiageswaran S, Franco-Elizondo R, Jayakar A, Hosni A, Nair A, Badr MS. Effect of age on long-term facilitation and chemosensitivity during NREM sleep. J Appl Physiol (1985). 2015 Nov 15;119(10):1088-96. doi: 10.1152/japplphysiol.00030.2015. Epub 2015 Aug 27.

  PMID: 26316510 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Central; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Susmita Chowdhuri
• Organization: John D. Dingell VA Medical Center

susmita.chowdhuri@va.gov

313 576 1000

Study Officials

• Susmita Chowdhuri, MD

  John D. Dingell VA Medical Center, Detroit, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)