Comparison Study of the ICONâ„¢ Auto Series With and Without SensAwakeâ„¢ and ThermoSmartâ„¢ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients

NCT ID: NCT01517763

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-09-30

Brief Summary

A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICONâ„¢ AT with SensAwakeâ„¢ and ThermoSmartâ„¢ 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, SensAwakeâ„¢, ThermoSmartâ„¢) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional CPAP

Fisher \& Paykel HC244â„¢

Group Type: PLACEBO_COMPARATOR

Conventional CPAP Therapy

Intervention Type: DEVICE

HC244 devices without Thermosmart or SensAwake

CPAP without Humidification

Fixed pressure ICONâ„¢ without ThermoSmartâ„¢

Group Type: ACTIVE_COMPARATOR

Fixed pressure ICONâ„¢ without ThermoSmartâ„¢

Intervention Type: DEVICE

Fixed pressure CPAP therapy using ICONâ„¢ without ThermoSmartâ„¢ or SensAwakeâ„¢

APAP with all technologies

Auto ICONâ„¢ with SensAwakeâ„¢ and ThermoSmartâ„¢

Group Type: EXPERIMENTAL

Auto ICONâ„¢ with SensAwakeâ„¢ and ThermoSmartâ„¢

Intervention Type: DEVICE

APAP therapy using Auto ICONâ„¢ with SensAwakeâ„¢ and ThermoSmartâ„¢

Interventions

Conventional CPAP Therapy

HC244 devices without Thermosmart or SensAwake

Intervention Type: DEVICE

Fixed pressure ICONâ„¢ without ThermoSmartâ„¢

Fixed pressure CPAP therapy using ICONâ„¢ without ThermoSmartâ„¢ or SensAwakeâ„¢

Intervention Type: DEVICE

Auto ICONâ„¢ with SensAwakeâ„¢ and ThermoSmartâ„¢

APAP therapy using Auto ICONâ„¢ with SensAwakeâ„¢ and ThermoSmartâ„¢

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 SensAwakeâ„¢ or ThermoSmartâ„¢ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sleep Health Centers

OTHER

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sleep HealthCenters

Brighton, Massachusetts, United States

Countries

United States

Other Identifiers

FPH-SA09-01

Identifier Type: -

Identifier Source: org_study_id