Obesity Hypoventilation SyndromeNCT02726048
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
A study testing Simplus/Eson in people with Obesity Hypoventilation Syndrome and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Germany.
Trial summary
This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Simplus/Eson
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Jul 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+
- Existing full face mask user or a nasal mask user
- Prescribed NIV therapy for at least 3 months
Who cannot join
- Inability to give informed consent
- Pregnant or think they may be pregnant
- Anatomical or physiological conditions making NIVtherapy inappropriate
- Patients who are in a coma or decreased level of consciousness
- Existing Simplus and Eson users
Trial locations and contacts
1 site in 1 country.
About this study
This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy
Read the detailed description
Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.
- Conditions
- Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease
- Being tested
- Simplus/Eson
- Medical subject headings
- Obesity Hypoventilation Syndrome, Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplus/EsonDevice
Released product Simplus and Eson masks
| Study group | Role | What they receive |
|---|---|---|
| Full face/Nasal masks | Experimental | Simplus/Eson Receives: Device: Simplus/Eson |
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
Measured: 2 weeks
Secondary outcomes (3)
Subjective measurement of Leak
Questionnaire
Measured: 2 weeks
Subjective measurement of Comfort
Questionnaire
Measured: 2 weeks
Subjective measurement of Ease of Use
Questionnaire
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Fisher \& Paykel Healthcare placed an administrative hold on the Simplus and Eson Non-Invasive Ventilation Evaluation study being conducted at Charite, Berlin
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.
- 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
- Ingo Fietze, Professor, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726048
- Sponsor's protocol ID
- CIA178
- Status last verified
- Jul 2018
- First submitted
- 29 Mar 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
- ClinicalTrials.gov ID
- NCT02726048
- Acronym / sponsor ID
- CIA178
- Conditions
- Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Fisher \& Paykel Healthcare placed an administrative hold on the Simplus and Eson Non-Invasive Ventilation Evaluation study being conducted at Charite, Berlin
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Apr 2016 (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 designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy
Detailed description
Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.
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: Simplus/EsonSimplus/Eson |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18+
- Existing full face mask user or a nasal mask user
- Prescribed NIV therapy for at least 3 months
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Pregnant or think they may be pregnant
- Anatomical or physiological conditions making NIVtherapy inappropriate
- Patients who are in a coma or decreased level of consciousness
- Existing Simplus and Eson users
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 |
|---|---|---|
| Simplus/EsonReleased product Simplus and Eson masks | Device | Full face/Nasal masks |
Primary outcome
Objective Leak data
Time frame: 2 weeks
Obtained from the participant's device
3 secondary outcomes
Subjective measurement of Leak
Time frame: 2 weeks
Subjective measurement of Comfort
Time frame: 2 weeks
Subjective measurement of Ease of Use
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Fisher \& Paykel Healthcare placed an administrative hold on the Simplus and Eson Non-Invasive Ventilation Evaluation study being conducted at Charite, Berlin). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Ingo Fietze, Professor principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplus/Eson in people with Obesity Hypoventilation Syndrome and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Germany.
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 5 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 2 Aug 2018. 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 Germany. 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: Fisher \& Paykel Healthcare placed an administrative hold on the Simplus and Eson Non-Invasive Ventilation Evaluation study being conducted at Charite, Berlin). 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: 2 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 2 Aug 2018.