ClinicalTrials.gg
CompletedNCT01575665HVMASKEUpdated May 19, 2016

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

An interventional study of Partial Rebreathing Mask in Hyperventilation, Chronic Idiopathic Hyperventilation and Dysfunctional Breathing, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-19.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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),.

02

Conditions studied

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

Keywords

  • Hyperventilation
  • Chronic Idiopathic Hyperventilation
  • Dysfunctional Breathing
  • Respiratory Alkalosis
  • Respiratory Acidosis
03

In context

Hyperventilation

43 studies on the registry are indexed under Hyperventilation; 6 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 31 interventional studies indexed under Hyperventilation.

Browse Hyperventilation studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Chronic idiopathic hyperventilation, i.e.:

  • PCO2 level below 4.7 kPa AND
  • SBE value more negative than -1.0

Exclusion criteria

Exclusion Criteria:

  • Oxygen saturation of 95% or lower at rest
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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

Interventions

  • DevicePartial Rebreathing Mask

    Inducing normal CO2 for two hours a day for four weeks

    Also known as: CDA mask, Balancair Mask

06

What researchers measure

Primary outcomes

  1. Blood gas and acid/base status

    pH, PCO2, PO2, Standard Base Excess

    Time frame: Once every week in the treatment period of four weeks

Secondary outcomes

  1. Hyperventilation symptoms

    Nijmegen Questionnaire

    Time frame: once a week

  2. Breath Hold Tolerance

    Time frame: once a week

  3. Spirometric values

    FEV1, FVC

    Time frame: once a week

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, DK-8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01575665
Collaborators
Rehaler
Responsible party
Sponsor
First posted
Apr 11, 2012
Start date
Feb 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
May 19, 2016

Study contacts

Ronald Dahl
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion