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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Blood gas and acid/base status [ Time Frame: Once every week in the treatment period of four weeks ]pH, PCO2, PO2, Standard Base Excess
- Hyperventilation symptoms [ Time Frame: once a week ]Nijmegen Questionnaire
- Breath Hold Tolerance [ Time Frame: once a week ]
- Spirometric values [ Time Frame: once a week ]FEV1, FVC
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
|Aarhus University Hospital|
|Aarhus, Denmark, DK-8000|
|Principal Investigator:||Ronald Dahl||Aarhus University Hospital|