Obesity Hypoventilation SyndromeNCT02486380
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
A study testing Toffee full face mask/toffee nasal mask in people with Obesity Hypoventilation Syndrome, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- Toffee full face mask/toffee nasal mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jul 2015to Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18+
- Diagnosed with OHS by a practicing physician
- Existing full face mask user or a nasal mask user
- Prescribed PAP therapy (Bi-Level or CPAP)
Who cannot join
- Inability to give informed consent
- Pregnant or think they may be pregnant
- Anatomical or physiological conditions making PAP therapy inappropriate
- Patients requiring supplemental oxygen with their PAP device
- Patients who are in a coma or decreased level of consciousness
- Existing Toffee full face and Toffee nasal mask users
- No arterial PCO2 value from their medical records
Trial locations and contacts
1 site in 1 country.
About this study
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.
Read the detailed description
Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F\&P Toffee Full face (if they are existing full face users) or F\&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- Toffee full face mask/toffee nasal mask
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toffee full face mask/toffee nasal maskDevice
Toffee full face mask/toffee nasal mask
| Study group | Role | What they receive |
|---|---|---|
| Full face/Nasal masks | Experimental | Toffee Full face/Toffee nasal Receives: Device: Toffee full face mask/toffee nasal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Leak data
Obtained from the participant's device and polysomnography (PSG)
Measured: 1 night
Secondary outcomes (6)
Subjective measurement of Leak
Questionnaire
Measured: 1 night
Comfort
Questionnaire
Measured: 1 night
Ease of use
Questionnaire
Measured: 1 night
Sleep efficiency
Obtained through the PSG
Measured: 1 night
Wake after Sleep Onset (WASO)
Obtained through the PSG
Measured: 1 night
Arousal Index (AI)
Obtained through the PSG
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Recruitment terminated permanently due to limited resource to recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation SyndromeStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhavi Ogra, BSc, Principal investigator, Fisher & Paykel Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486380
- Sponsor's protocol ID
- CIA-162
- Status last verified
- Jun 2022
- First submitted
- 25 Jun 2015
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
- ClinicalTrials.gov ID
- NCT02486380
- Acronym / sponsor ID
- CIA-162
- Conditions
- Obesity Hypoventilation Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment terminated permanently due to limited resource to recruit.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 Jul 2015 (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.
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.
Detailed description
Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F\&P Toffee Full face (if they are existing full face users) or F\&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full face/Nasal masks | Experimental | Device: Toffee full face mask/toffee nasal maskToffee Full face/Toffee nasal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18+
- Diagnosed with OHS by a practicing physician
- Existing full face mask user or a nasal mask user
- Prescribed PAP therapy (Bi-Level or CPAP)
Key exclusion criteria (7 listed)
- Inability to give informed consent
- Pregnant or think they may be pregnant
- Anatomical or physiological conditions making PAP therapy inappropriate
- Patients requiring supplemental oxygen with their PAP device
- Patients who are in a coma or decreased level of consciousness
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 |
|---|---|---|
| Toffee full face mask/toffee nasal maskToffee full face mask/toffee nasal mask | Device | Full face/Nasal masks |
Primary outcome
Objective Leak data
Time frame: 1 night
Obtained from the participant's device and polysomnography (PSG)
6 secondary outcomes
Subjective measurement of Leak
Time frame: 1 night
Comfort
Time frame: 1 night
Ease of use
Time frame: 1 night
Sleep efficiency
Time frame: 1 night
Wake after Sleep Onset (WASO)
Time frame: 1 night
Arousal Index (AI)
Time frame: 1 night
Results and safety
The study was stopped early (reason given: Recruitment terminated permanently due to limited resource to recruit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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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.
Bhavi Ogra, BSc principal investigator
Fisher & Paykel Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toffee full face mask/toffee nasal mask in people with Obesity Hypoventilation Syndrome, 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 4 inclusion and 7 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 24 Jun 2022. 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: Recruitment terminated permanently due to limited resource to recruit.). 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?
Objective Leak data (time frame: 1 night). 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 24 Jun 2022.