Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures

This study has been completed.
Sponsor:
Information provided by:
Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:
NCT01408329
First received: July 28, 2011
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like device to expose users to controlled fluctuations in air pressure. It is designed to promote quicker altitude acclimatization, thus promoting improvements in exercise capacity at altitude and, possibly, at sea level. However, over the past few years, anecdotal stories from users of the device suggest that the CVAC treatments might be causing changes beyond the expected endurance exercise performance benefits. Therefore, the purpose of the study is to obtain data on some of the previous anecdotal claims regarding the device (e.g. increases in strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint swelling) as well as to obtain broad questionnaire data in order to identify more specific variables to investigate in future studies.


Condition Intervention
Hypoxia
Device: CVAC Device (Cyclic Variations in Altitude Conditioning)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures

Further study details as provided by Palo Alto Institute for Research and Education, Inc:

Primary Outcome Measures:
  • Blood Glucose concentration [ Time Frame: 10 weeks of exposure ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2007
Study Completion Date: August 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Sham altitude changes
Device: CVAC Device (Cyclic Variations in Altitude Conditioning)
A hypobaric hypoxia chamber
Experimental: Hypoxic intervention Device: CVAC Device (Cyclic Variations in Altitude Conditioning)
A hypobaric hypoxia chamber

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy middle aged men at risk for metabolic syndrome

Exclusion Criteria:

  • Uncontrolled hypertension,
  • sensitive ears,
  • anything that would preclude person from sustaining rapid pressure changes
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01408329

Sponsors and Collaborators
Palo Alto Institute for Research and Education, Inc
Investigators
Principal Investigator: Anne Friedlander, PhD Veterans Affairs Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Anne Friedlander, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01408329     History of Changes
Other Study ID Numbers: FRI0016
Study First Received: July 28, 2011
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014