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Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study (HVMASKE)

Primary Purpose

Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Partial Rebreathing Mask
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperventilation focused on measuring Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing, Respiratory Alkalosis, Respiratory Acidosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic idiopathic hyperventilation, i.e.:

  • PCO2 level below 4.7 kPa AND
  • SBE value more negative than -1.0

Exclusion Criteria:

  • Oxygen saturation of 95% or lower at rest

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Partial Rebreathing Mask

Arm Description

A novel membrane breathing mask which facilitates a partial rebreathing of expired gas (thereby raising systemic CO2), while allowing a diffusion of oxygen from the atmosphere to the user, through the membranes.

Outcomes

Primary Outcome Measures

Blood gas and acid/base status
pH, PCO2, PO2, Standard Base Excess

Secondary Outcome Measures

Hyperventilation symptoms
Nijmegen Questionnaire
Breath Hold Tolerance
Spirometric values
FEV1, FVC

Full Information

First Posted
April 10, 2012
Last Updated
May 18, 2016
Sponsor
University of Aarhus
Collaborators
Rehaler
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1. Study Identification

Unique Protocol Identification Number
NCT01575665
Brief Title
Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study
Acronym
HVMASKE
Official Title
CO2 Rebreathing by a Partial Rebreathing Mask as a Treatment of Chronic Idiopathic Hyperventilation - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Rehaler

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing which has proven hard to treat effectively. The investigators hypothesised that by periodically inducing normocapnia over several weeks, it would be possible to raise the normal resting level/set point of CO2 and achieve a reduction of symptoms. Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing mask. The mask was used to induce normocapnia in these chronically hypocapnic patients. Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline and once each week at least three hours after mask use, as well as spirometric values, breath holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire (NQ),.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing, Respiratory Alkalosis
Keywords
Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing, Respiratory Alkalosis, Respiratory Acidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partial Rebreathing Mask
Arm Type
Experimental
Arm Description
A novel membrane breathing mask which facilitates a partial rebreathing of expired gas (thereby raising systemic CO2), while allowing a diffusion of oxygen from the atmosphere to the user, through the membranes.
Intervention Type
Device
Intervention Name(s)
Partial Rebreathing Mask
Other Intervention Name(s)
CDA mask, Balancair Mask
Intervention Description
Inducing normal CO2 for two hours a day for four weeks
Primary Outcome Measure Information:
Title
Blood gas and acid/base status
Description
pH, PCO2, PO2, Standard Base Excess
Time Frame
Once every week in the treatment period of four weeks
Secondary Outcome Measure Information:
Title
Hyperventilation symptoms
Description
Nijmegen Questionnaire
Time Frame
once a week
Title
Breath Hold Tolerance
Time Frame
once a week
Title
Spirometric values
Description
FEV1, FVC
Time Frame
once a week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic idiopathic hyperventilation, i.e.: PCO2 level below 4.7 kPa AND SBE value more negative than -1.0 Exclusion Criteria: Oxygen saturation of 95% or lower at rest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Dahl
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

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Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study

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