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

NCT01575665 | Completed DMC

• 1 other identifier: 8313-86
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Hyperventilation; Chronic Idiopathic Hyperventilation; Dysfunctional Breathing; Respiratory Alkalosis; Respiratory Acidosis

Outcome Measures

Primary Outcomes (1)

• Blood gas and acid/base status

  pH, PCO2, PO2, Standard Base Excess

  Once every week in the treatment period of four weeks

Secondary Outcomes (3)

• Hyperventilation symptoms

  once a week

• Breath Hold Tolerance

  once a week

• Spirometric values

  once a week

Study Arms (1)

Partial Rebreathing Mask

EXPERIMENTAL

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

Interventions

Partial Rebreathing Mask DEVICE

Inducing normal CO2 for two hours a day for four weeks

Also known as: CDA mask, Balancair Mask

Partial Rebreathing Mask

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic idiopathic hyperventilation, i.e.:
• PCO2 level below 4.7 kPa AND
• SBE value more negative than -1.0

You may not qualify if:

• Oxygen saturation of 95% or lower at rest

Sponsors & Collaborators

• University of Aarhus: lead
• Rehaler: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

Hyperventilation; Alkalosis, Respiratory; Acidosis, Respiratory

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Alkalosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Respiratory Insufficiency; Acidosis

Study Officials

• Ronald Dahl

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 11, 2012
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

DK (1)