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

Primary Purpose

Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CVAC Device (Cyclic Variations in Altitude Conditioning)
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypoxia

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Control

    Hypoxic intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Plasma Glucose Concentration

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2011
    Last Updated
    August 19, 2015
    Sponsor
    Palo Alto Veterans Institute for Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01408329
    Brief Title
    Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures
    Acronym
    CVAC
    Official Title
    Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Palo Alto Veterans Institute for Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxia

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    Hypoxic intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    CVAC Device (Cyclic Variations in Altitude Conditioning)
    Intervention Description
    A hypobaric hypoxia chamber
    Primary Outcome Measure Information:
    Title
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne Friedlander, PhD
    Organizational Affiliation
    Veterans Affairs Palo Alto Health Care System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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