HyperventilationHVMASKENCT01575665
Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study
A study testing Partial Rebreathing Mask in people with Hyperventilation and Chronic Idiopathic Hyperventilation, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing
- What is being tested?
- Partial Rebreathing Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic idiopathic hyperventilation, i.e.:
- PCO2 level below 4.7 kPa AND
- SBE value more negative than -1.0
Who cannot join
- Oxygen saturation of 95% or lower at rest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CO2 Rebreathing by a Partial Rebreathing Mask as a Treatment of Chronic Idiopathic Hyperventilation - 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),.
- Conditions
- Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing, Respiratory Alkalosis
- Being tested
- Partial Rebreathing Mask
- Keywords
- Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing, Respiratory Alkalosis, Respiratory Acidosis
- Medical subject headings
- Hyperventilation, Alkalosis, Respiratory, Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Rebreathing MaskDevice
Also called CDA mask, Balancair Mask
Inducing normal CO2 for two hours a day for four weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Partial Rebreathing Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood gas and acid/base status
pH, PCO2, PO2, Standard Base Excess
Measured: Once every week in the treatment period of four weeks
Secondary outcomes (3)
Hyperventilation symptoms
Nijmegen Questionnaire
Measured: once a week
Breath Hold Tolerance
Measured: once a week
Spirometric values
FEV1, FVC
Measured: once a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperventilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Rehaler
- Responsible party
- Sponsor
- Investigators
- Ronald Dahl, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575665
- Sponsor's protocol ID
- 8313-86
- Acronym
- HVMASKE
- Status last verified
- May 2016
- First submitted
- 10 Apr 2012
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 Rebreathing by a Partial Rebreathing Mask as a Treatment of Chronic Idiopathic Hyperventilation - a Pilot Study
- ClinicalTrials.gov ID
- NCT01575665
- Acronym / sponsor ID
- HVMASKE / 8313-86
- Conditions
- Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing, Respiratory Alkalosis
- Keywords
- Hyperventilation, Chronic Idiopathic Hyperventilation, Dysfunctional Breathing, Respiratory Alkalosis, Respiratory Acidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Rehaler
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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),.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Rebreathing Mask | Experimental | Device: Partial Rebreathing MaskA 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PCO2 level below 4.7 kPa AND
- SBE value more negative than -1.0
Key exclusion criteria (1 listed)
- Oxygen saturation of 95% or lower at rest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Rebreathing MaskAlso: CDA mask, Balancair MaskInducing normal CO2 for two hours a day for four weeks | Device | Partial Rebreathing Mask |
Primary outcome
Blood gas and acid/base status
Time frame: Once every week in the treatment period of four weeks
pH, PCO2, PO2, Standard Base Excess
3 secondary outcomes
Hyperventilation symptoms
Time frame: once a week
Breath Hold Tolerance
Time frame: once a week
Spirometric values
Time frame: once a week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Dahl principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Rebreathing Mask in people with Hyperventilation and Chronic Idiopathic Hyperventilation, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood gas and acid/base status (time frame: Once every week in the treatment period of four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.