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Completed

NCT Number: NCT01575665

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

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),.

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Key information

Conditions

Hyperventilation Acid-Base Imbalance Acidosis Acidosis, Respiratory Alkalosis Alkalosis, Respiratory Chronic Idiopathic Hyperventilation Dysfunctional Breathing Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Alkalosis Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partial Rebreathing Mask

Device

Inducing normal CO2 for two hours a day for four weeks

Other names: CDA mask, Balancair Mask

Primary outcomes

  1. Blood gas and acid/base status

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

    pH, PCO2, PO2, Standard Base Excess

Secondary outcomes

  1. Hyperventilation symptoms

    Time frame: once a week

    Nijmegen Questionnaire

  2. Breath Hold Tolerance

    Time frame: once a week

  3. Spirometric values

    Time frame: once a week

    FEV1, FVC

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Rehaler

Registry information

Official study title

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

Acronym: HVMASKE

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 11, 2012
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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