Trial Outcomes & Findings for Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients (NCT NCT01517763)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

On day 90 after randomization

Results posted on

2019-06-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Conventional CPAP Fisher \& Paykel HC244™ Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake	CPAP Without Humidification Fixed pressure ICON™ without ThermoSmart™ Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™	APAP With All Technologies Auto ICON™ with SensAwake™ and ThermoSmart™ Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™
Overall Study STARTED	0	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: On day 90 after randomization

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: On day 90 after randomization

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Conventional CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CPAP Without Humidification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

APAP With All Technologies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Scientist

Fisher and Paykel Healthcare

Phone: +64 09 574 0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place