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

Hyperventilation Clinical Trial

— HVMASKE  

Official title:

CO2 Rebreathing by a Partial Rebreathing Mask as a Treatment of Chronic Idiopathic Hyperventilation - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575665
• Other study ID #: 8313-86
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: May 18, 2016
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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),.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alkalosis
• Alkalosis, Respiratory
• Chronic Idiopathic Hyperventilation
• Dysfunctional Breathing
• Hyperventilation
• Respiratory Alkalosis
• Respiratory Aspiration

Intervention

Device:
• Partial Rebreathing Mask
Inducing normal CO2 for two hours a day for four weeks

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Balancair ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood gas and acid/base status	pH, PCO2, PO2, Standard Base Excess	Once every week in the treatment period of four weeks	No
Secondary	Hyperventilation symptoms	Nijmegen Questionnaire	once a week	No
Secondary	Breath Hold Tolerance		once a week	No
Secondary	Spirometric values	FEV1, FVC	once a week	No