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

August 19, 2015 updated by: Anne Friedlander, Palo Alto Veterans Institute for Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Sham altitude changes - The CVAC device consists of a small pod-like chamber attached to a computer system that controls a strong pump that can draw air rapidly out of the chamber to increase the simulated altitude. The sham-treated group (SH) was exposed to regular, slowly-fluctuating pressures that reached a maximum altitude of 607 m for all 30 sessions. Sham sessions mimicked the noises and initial pressure-change sensations created in the active sessions, thus giving naıve subjects the impression that they were experiencing altitude treatment. All subjects were blind to their elevation throughout the intervention.
Device: CVAC Device (Cyclic Variations in Altitude Conditioning)
A hypobaric hypoxia chamber
Experimental: Hypoxic intervention
Cyclic Hypobaric Hypoxia (CHH) subjects were given 40 min sessions inside the CVAC device per day (two 20 min sessions sequentially per day), 3 days a week for 10 weeks, for a total of 30 sessions or 20 hours. After familiarization sessions, pre-programmed sessions were administered, progressing from Tier 1 to 5. Subjects rotated through three pre-programmed sessions per Tier and each session varied the pattern and rate of hypoxic fluctuations, so that subjects would experience a constantly changing stimulus at each elevation. Five weeks were allotted to progress from Tier 1 (3048 m) to Tier 4 (5486 m). At Tier 5 (6096 m), there was an additional 5 weeks of exposure.
Device: CVAC Device (Cyclic Variations in Altitude Conditioning)
A hypobaric hypoxia chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma Glucose Concentration
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Investigators

  • Principal Investigator: Anne Friedlander, PhD, Veterans Affairs Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRI0016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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