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

NCT ID: NCT01575665

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-06-30

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),.

Conditions

Hyperventilation; Chronic Idiopathic Hyperventilation; Dysfunctional Breathing; Respiratory Alkalosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Partial Rebreathing Mask

Intervention Type: DEVICE

Inducing normal CO2 for two hours a day for four weeks

Interventions

Partial Rebreathing Mask

Inducing normal CO2 for two hours a day for four weeks

Intervention Type: DEVICE

Other Intervention Names

CDA mask; Balancair Mask

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rehaler

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Dahl

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

8313-86

Identifier Type: -

Identifier Source: org_study_id