Sleep Apnea, ObstructiveNCT01517763

Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients

A study testing Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™ and Auto ICON™ with SensAwake™ and ThermoSmart™ in people with Sleep Apnea, Obstructive, run by Fisher and Paykel Healthcare at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Sleep Apnea, Obstructive
What is being tested?: Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™ and Auto ICON™ with SensAwake™ and ThermoSmart™
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Sep 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
Successful titration Polysomnography (PSG).
Fluency in both written and spoken English.

Who cannot join

Participants prescribed and fitted with any PAP device in the past 2 years.
Contraindicated for CPAP or AutoCPAP therapy.
Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
If the physician objects to their patient taking part in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sleep HealthCenters
Brighton, Massachusetts, 02135

Other trials in United States

About this study

A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).

Conditions: Sleep Apnea, Obstructive
Being tested: Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™, Auto ICON™ with SensAwake™ and ThermoSmart™
Keywords: Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure, ICON, ThermoSmart, SensAwake
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.

Conventional CPAP TherapyDevice
HC244 devices without Thermosmart or SensAwake
Fixed pressure ICON™ without ThermoSmart™Device
Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™
Auto ICON™ with SensAwake™ and ThermoSmart™Device
APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™

Study groups in NCT01517763
Study group	Role	What they receive
Conventional CPAP	Placebo comparator	Fisher \& Paykel HC244™ Receives: Device: Conventional CPAP Therapy
CPAP without Humidification	Active comparator	Fixed pressure ICON™ without ThermoSmart™ Receives: Device: Fixed pressure ICON™ without ThermoSmart™
APAP with all technologies	Experimental	Auto ICON™ with SensAwake™ and ThermoSmart™ Receives: Device: Auto ICON™ with SensAwake™ and ThermoSmart™

What is being measured

The primary outcome is the main question the study is designed to answer.

Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
Measured: On day 90 after randomization

Secondary outcomes (1)

Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.
Measured: On day 90 after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Sep 2014

First posted25 Jan 2012 (estimated)
Study startJan 2012
Primary completionSep 2014
Study completionSep 2014

Why it stopped: The site closed down, therefore the study has been terminated.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep Apnea, ObstructiveStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01517763
Sponsor's protocol ID: FPH-SA09-01
Status last verified: May 2019
First submitted: 17 Jan 2012
Last updated: 10 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Sleep Apnea, Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
ClinicalTrials.gov ID: NCT01517763
Acronym / sponsor ID: FPH-SA09-01
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure, ICON, ThermoSmart, SensAwake
Study type: Interventional
Recruitment status: TerminatedReason stopped: The site closed down, therefore the study has been terminated.
Enrolment: 32 participants (actual)
Lead sponsor: Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
Collaborators: Sleep Health Centers
Study start: Jan 2012
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 25 Jan 2012 (estimated)
Results: Posted 10 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Conventional CPAP	Placebo comparator	Device: Conventional CPAP TherapyFisher \& Paykel HC244™
CPAP without Humidification	Active comparator	Device: Fixed pressure ICON™ without ThermoSmart™Fixed pressure ICON™ without ThermoSmart™
APAP with all technologies	Experimental	Device: Auto ICON™ with SensAwake™ and ThermoSmart™Auto ICON™ with SensAwake™ and ThermoSmart™

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
Successful titration Polysomnography (PSG).
Fluency in both written and spoken English.

Key exclusion criteria (8 listed)

Participants prescribed and fitted with any PAP device in the past 2 years.
Contraindicated for CPAP or AutoCPAP therapy.
Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.

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
Conventional CPAP TherapyHC244 devices without Thermosmart or SensAwake	Device	Conventional CPAP
Fixed pressure ICON™ without ThermoSmart™Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™	Device	CPAP without Humidification
Auto ICON™ with SensAwake™ and ThermoSmart™APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™	Device	APAP with all technologies

Primary outcome

Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
Time frame: On day 90 after randomization

1 secondary outcome

Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.
Time frame: On day 90 after randomization

Results and safety

Results posted to the registry on 10 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional CPAP	0	0
CPAP Without Humidification	0	0
APAP With All Technologies	0	0

Primary outcome: Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.

Time frame: On day 90 after randomization

Population analysed: This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Conventional CPAP	0 of 0	0 of 0
CPAP Without Humidification	0 of 0	0 of 0
APAP With All Technologies	0 of 0	0 of 0

Limitations and caveats (from the sponsor): This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sleep Apnea, Obstructive

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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?

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 8 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 10 Jun 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software. (time frame: On day 90 after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01517763.

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 10 Jun 2019.