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

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ClinicalTrials.gov Identifier: NCT01575665
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
BalancAir
Information provided by (Responsible Party):
University of Aarhus

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),.


Condition or disease Intervention/treatment Phase
Hyperventilation Chronic Idiopathic Hyperventilation Dysfunctional Breathing Respiratory Alkalosis Device: Partial Rebreathing Mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CO2 Rebreathing by a Partial Rebreathing Mask as a Treatment of Chronic Idiopathic Hyperventilation - a Pilot Study
Study Start Date : February 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Partial Rebreathing Mask
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.
Device: Partial Rebreathing Mask
Inducing normal CO2 for two hours a day for four weeks
Other Names:
  • CDA mask
  • Balancair Mask




Primary Outcome Measures :
  1. Blood gas and acid/base status [ Time Frame: Once every week in the treatment period of four weeks ]
    pH, PCO2, PO2, Standard Base Excess


Secondary Outcome Measures :
  1. Hyperventilation symptoms [ Time Frame: once a week ]
    Nijmegen Questionnaire

  2. Breath Hold Tolerance [ Time Frame: once a week ]
  3. Spirometric values [ Time Frame: once a week ]
    FEV1, FVC



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575665


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
BalancAir
Investigators
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Principal Investigator: Ronald Dahl Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01575665    
Other Study ID Numbers: 8313-86
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Keywords provided by University of Aarhus:
Hyperventilation
Chronic Idiopathic Hyperventilation
Dysfunctional Breathing
Respiratory Alkalosis
Respiratory Acidosis
Additional relevant MeSH terms:
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Respiratory Aspiration
Hyperventilation
Alkalosis, Respiratory
Alkalosis
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Acid-Base Imbalance
Metabolic Diseases