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

Hypoxia Clinical Trial

— CVAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408329
• Other study ID #: FRI0016
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: August 19, 2015
• Start date: January 2007
• Est. completion date: August 2010

Study information

• Verified date: August 2015
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• CVAC Device (Cyclic Variations in Altitude Conditioning)
A hypobaric hypoxia chamber

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose Concentration		Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10-12 h fast the morning after a CVAC session (except for baseline).	No