NCT01517763

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

May 1, 2019

Enrollment Period

2.7 years

First QC Date

January 17, 2012

Results QC Date

May 19, 2019

Last Update Submit

May 19, 2019

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep ApneaHumidificationContinuous Positive Airway PressureICONThermoSmartSensAwake

Outcome Measures

Primary Outcomes (1)

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

    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.

    On day 90 after randomization

Study Arms (3)

Conventional CPAP

PLACEBO COMPARATOR

Fisher \& Paykel HC244™

Device: Conventional CPAP Therapy

CPAP without Humidification

ACTIVE COMPARATOR

Fixed pressure ICON™ without ThermoSmart™

Device: Fixed pressure ICON™ without ThermoSmart™

APAP with all technologies

EXPERIMENTAL

Auto ICON™ with SensAwake™ and ThermoSmart™

Device: Auto ICON™ with SensAwake™ and ThermoSmart™

Interventions

Conventional CPAP TherapyDEVICE

HC244 devices without Thermosmart or SensAwake

Conventional CPAP
Fixed pressure ICON™ without ThermoSmart™DEVICE

Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™

CPAP without Humidification
Auto ICON™ with SensAwake™ and ThermoSmart™DEVICE

APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™

APAP with all technologies

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep HealthCenters

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Clinical Research Scientist
Organization
Fisher and Paykel Healthcare
CPAPtrial@fphcare.co.nz
+64 09 574 0100

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 10, 2019

Results First Posted

June 10, 2019

Record last verified: 2019-05

Locations

US(1)