Obstructive Sleep ApneaNCT03247907
Humidification Needs
A study testing Condition A: CPAP with No Humidification, Condition B: CPAP with No Humidification and Condition C: CPAP with Cold Passover in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Condition A: CPAP with No Humidification, Condition B: CPAP with No Humidification and Condition C: CPAP with Cold Passover
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNew Zealand
- Study dates
- 9 Oct 2017to 30 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 and over
Who cannot join
- Inability to give consent
- Currently pregnant or think they may be pregnant
- Current nasal symptoms or chronic nasal disease
- Contraindicated for PAP therapy
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Fisher and Paykel Healthcare
East Tamaki, Auckland, 2013
About this study
A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Condition A: CPAP with No Humidification, Condition B: CPAP with No Humidification, Condition C: CPAP with Cold Passover, Condition D: CPAP with Modified humidifier, Condition E: CPAP with Ambient Tracking
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condition A: CPAP with No HumidificationDevice
CPAP with No Humidification with no mouth leak
Condition B: CPAP with No HumidificationDevice
CPAP with No Humidification with mouth leak
Condition C: CPAP with Cold PassoverDevice
CPAP with Cold Passover with mouth leak
Condition D: CPAP with Modified humidifierDevice
CPAP with Modified humidifier with mouth leak
Condition E: CPAP with Ambient TrackingDevice
CPAP with Ambient Tracking with mouth leak
Condition F: CPAP with Heated HumidificationDevice
CPAP with Heated Humidification at default setting with mouth leak
Condition G: CPAP with Heated HumidificationDevice
CPAP with Heated Humidification at max setting with mouth leak
Condition H: CPAP with New level humidificationDevice
CPAP with New level humidification with mouth leak
| Study group | Role | What they receive |
|---|---|---|
| Condition A: CPAP with No Humidification | Active comparator | CPAP with No Humidification with no mouth leak Receives: Device: Condition A: CPAP with No Humidification |
| Condition B: CPAP with No Humidification | Active comparator | CPAP with No Humidification with mouth leak Receives: Device: Condition B: CPAP with No Humidification |
| Condition C: CPAP with Cold Passover humidifier | Active comparator | CPAP with Cold Passover humidifier with mouth leak Receives: Device: Condition C: CPAP with Cold Passover |
| Condition D: CPAP with Modified Humidifier | Active comparator | CPAP with Modified Humidifier with mouth leak Receives: Device: Condition D: CPAP with Modified humidifier |
| Condition E: CPAP with Ambient Tracking | Active comparator | CPAP with Ambient Tracking with mouth leak Receives: Device: Condition E: CPAP with Ambient Tracking |
| Condition F: CPAP with Heated Humidification | Active comparator | CPAP with Heated Humidification at default setting with mouth leak Receives: Device: Condition F: CPAP with Heated Humidification |
| Condition G: CPAP with Heated Humidification | Active comparator | CPAP with Heated Humidification at max setting with mouth leak Receives: Device: Condition G: CPAP with Heated Humidification |
| Condition H: CPAP with New level humidification | Active comparator | CPAP with New level humidification with mouth leak Receives: Device: Condition H: CPAP with New level humidification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Resistance
Will be measured by rhinomanometer or acoustic rhinometry
Measured: 8 Days
Evaluation of Nasal Dryness and Discomfort
Reported by participants using the Xero Questionnaire
Measured: 8 Days
Secondary outcomes (1)
Preference of Testing Condition
Measured by custom preference questionnaire
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start9 Oct 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Why it stopped: Trial was terminated by investigators due to equipment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247907
- Sponsor's protocol ID
- CIA-191
- Status last verified
- Apr 2019
- First submitted
- 7 Aug 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humidification Needs
- ClinicalTrials.gov ID
- NCT03247907
- Acronym / sponsor ID
- CIA-191
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated by investigators due to equipment difficulties
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 14 Aug 2017 (actual)
- 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.
A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Condition A: CPAP with No Humidification | Active comparator | Device: Condition A: CPAP with No HumidificationCPAP with No Humidification with no mouth leak |
| Condition B: CPAP with No Humidification | Active comparator | Device: Condition B: CPAP with No HumidificationCPAP with No Humidification with mouth leak |
| Condition C: CPAP with Cold Passover humidifier | Active comparator | Device: Condition C: CPAP with Cold PassoverCPAP with Cold Passover humidifier with mouth leak |
| Condition D: CPAP with Modified Humidifier | Active comparator | Device: Condition D: CPAP with Modified humidifierCPAP with Modified Humidifier with mouth leak |
| Condition E: CPAP with Ambient Tracking | Active comparator | Device: Condition E: CPAP with Ambient TrackingCPAP with Ambient Tracking with mouth leak |
| Condition F: CPAP with Heated Humidification | Active comparator | Device: Condition F: CPAP with Heated HumidificationCPAP with Heated Humidification at default setting with mouth leak |
| Condition G: CPAP with Heated Humidification | Active comparator | Device: Condition G: CPAP with Heated HumidificationCPAP with Heated Humidification at max setting with mouth leak |
| Condition H: CPAP with New level humidification | Active comparator | Device: Condition H: CPAP with New level humidificationCPAP with New level humidification with mouth leak |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 and over
Key exclusion criteria (4 listed)
- Inability to give consent
- Currently pregnant or think they may be pregnant
- Current nasal symptoms or chronic nasal disease
- Contraindicated for PAP therapy
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 |
|---|---|---|
| Condition A: CPAP with No HumidificationCPAP with No Humidification with no mouth leak | Device | Condition A: CPAP with No Humidification |
| Condition B: CPAP with No HumidificationCPAP with No Humidification with mouth leak | Device | Condition B: CPAP with No Humidification |
| Condition C: CPAP with Cold PassoverCPAP with Cold Passover with mouth leak | Device | Condition C: CPAP with Cold Passover humidifier |
| Condition D: CPAP with Modified humidifierCPAP with Modified humidifier with mouth leak | Device | Condition D: CPAP with Modified Humidifier |
| Condition E: CPAP with Ambient TrackingCPAP with Ambient Tracking with mouth leak | Device | Condition E: CPAP with Ambient Tracking |
| Condition F: CPAP with Heated HumidificationCPAP with Heated Humidification at default setting with mouth leak | Device | Condition F: CPAP with Heated Humidification |
| Condition G: CPAP with Heated HumidificationCPAP with Heated Humidification at max setting with mouth leak | Device | Condition G: CPAP with Heated Humidification |
| Condition H: CPAP with New level humidificationCPAP with New level humidification with mouth leak | Device | Condition H: CPAP with New level humidification |
Primary outcome
Nasal Resistance
Time frame: 8 Days
Will be measured by rhinomanometer or acoustic rhinometry
Evaluation of Nasal Dryness and Discomfort
Time frame: 8 Days
Reported by participants using the Xero Questionnaire
1 secondary outcome
Preference of Testing Condition
Time frame: 8 Days
Results and safety
The study was stopped early (reason given: Trial was terminated by investigators due to equipment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condition A: CPAP with No Humidification, Condition B: CPAP with No Humidification and Condition C: CPAP with Cold Passover in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Apr 2019. 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 New Zealand. 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 was stopped early (reason given: Trial was terminated by investigators due to equipment difficulties). Results are not available in the source record.
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?
Nasal Resistance (time frame: 8 Days). The study lists 2 primary outcomes in all. 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 Apr 2019.