Back to results

Juno Perth Clinical Trial

Primary Purpose

Respiratory Insufficiency, Obesity Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease (COPD)

Status

Terminated

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Juno

About this trial

This is an interventional treatment trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Subject has ability to provide written informed consent
Subject aged ≥18 years old
Subject has a diagnosis of COPD, OHS or NMD with sleep hypoventilation (historical PtCO2 increase overnight ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)
Subject is currently using non-invasive ventilation for ≥ 3 months
Subject with an AHI ≥ 5 hr. (as documented in diagnostic or pressure determination sleep study report)

Exclusion Criteria

Subjects not compliant on NIV (ie. < 4 hr/night)
Subjects with severe asthma
Subjects who are pregnant
Subjects on oxygen therapy (ie. >4 L/min)
Subjects with a tracheostomy
Subjects who are acutely ill, medically complicated or who are medically unstable
Subjects in whom PAP therapy is otherwise medically contraindicated
Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
Subjects who require ventilatory support during wakefulness
Subjects with the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, low blood pressure, cerebrospinal fluid leak, recent cranial surgery or trauma.
Subjects with severe developmental delay and who will not be able to follow tasks as instructed in the protocol.
Subjects who the investigator believes are unsuitable for inclusion because either:
- they do not comprehend English
- they are unable or unwilling to provide written informed consent
- they are physically unable to comply with the protocol
- they are unsuitable to participate in the trial for any other reason in the opinion of the investigator

Sites / Locations

Sir Charles Gairdner Hospital
University of Western Australia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Standard ST Mode

AutoEPAP iVAPS

Fixed EPAP iVAPS

Arm Description

Participants underwent the first PSG study (Titration Night 1) on ST Mode ( prior to going on AutoEPAP iVAPS or Fixed EPAP iVAPS) whilst receiving their standard NIV therapy through the clinical trial device "Juno". During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy.

Participants underwent a PSG study on the AutoEPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first.

Participants underwent a PSG study on the Fixed EPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation. Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first.

Outcomes

Primary Outcome Measures

Apnoea-Hypopnoea Index (AHI)

The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS

Secondary Outcome Measures

Oxygen Desaturation Index

Number of oxygen desaturations per hour of sleep

Mean Oxygen Saturation

Mean oxygen saturation recorded in the total sleep time

Time Spent Below 90% Oxygen Saturation

Time in minutes that the oxygen saturation was below 90%

Mean Transcutaneous Carbon Dioxide (PtcCo2)

Transcutaneous Carbon Dioxide measurement (TcCO2)

Sleep Duration

Time spent asleep

Sleep Efficacy

Sleep time divided by total time available for sleep

Sleep Latency-Wake After Sleep Onset Time

Time awake in minutes after initial sleep onset

Total Sleep Time Spent in Each Sleep Stage

Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)

Number of Respiratory Event Related Arousals/ Hour

Total number of respiratory event related arousals/hr over the entire sleep period

Number of Spontaneous Arousals/Hour

Number of spontaneous arousals/hr occurring over the entire total sleep time

Full Information

NCT ID

NCT02317042

First Posted

December 8, 2014

Last Updated

May 12, 2021

Sponsor

ResMed

Collaborators

Sir Charles Gairdner Hospital, The University of Western Australia

1. Study Identification

Unique Protocol Identification Number

NCT02317042

Brief Title

Juno Perth Clinical Trial

Official Title

The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Phase II not initiated for commercial reasons (no safety related issues)

Study Start Date

May 29, 2015 (Actual)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 29, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

Collaborators

Sir Charles Gairdner Hospital, The University of Western Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper airway obstruction. The study will be performed in two phases: In a sleep unit and in the home environment. The new therapy will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (iVAPS)".

Detailed Description

Phase I: AutoEPAP iVAPS will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (Fixed EPAP iVAPS)" in current NIV users with respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD),Obesity Hypoventilation Syndrome (OHS) or Neuromuscular Disease (NMD). Patients will spend a total of 3 nights in the sleep laboratory in the three modes described above. The apnoea-hypopnoea index will be the primary outcome measure. Phase II: AutoEPAP iVAPS will be compared to ST mode over a period of 7 nights in the patients' home. The mean EPAP setting of each device will be the primary outcome measure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency, Obesity Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease, Upper Airway Obstruction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard ST Mode

Arm Type

Active Comparator

Arm Description

Arm Title

AutoEPAP iVAPS

Arm Type

Experimental

Arm Description

Arm Title

Fixed EPAP iVAPS

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Juno

Other Intervention Name(s)

ResMed "Juno" Device

Intervention Description

Juno device set to ST mode with participant's current therapy settings.

Intervention Type

Device

Intervention Name(s)

Juno

Other Intervention Name(s)

ResMed "Juno" Device

Intervention Description

Juno device set to AutoEPAP iVAPS mode.

Intervention Type

Device

Intervention Name(s)

Juno

Other Intervention Name(s)

ResMed "Juno" Device

Intervention Description

Juno device set to Fixed EPAP iVAPS mode.

Primary Outcome Measure Information:

Title

Apnoea-Hypopnoea Index (AHI)

Description

The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS

Time Frame

1 night

Secondary Outcome Measure Information:

Title

Oxygen Desaturation Index

Description

Number of oxygen desaturations per hour of sleep

Time Frame

1 night

Title

Mean Oxygen Saturation

Description

Mean oxygen saturation recorded in the total sleep time

Time Frame

1 night

Title

Time Spent Below 90% Oxygen Saturation

Description

Time in minutes that the oxygen saturation was below 90%

Time Frame

1 night

Title

Mean Transcutaneous Carbon Dioxide (PtcCo2)

Description

Transcutaneous Carbon Dioxide measurement (TcCO2)

Time Frame

1 night

Title

Sleep Duration

Description

Time spent asleep

Time Frame

1 Night

Title

Sleep Efficacy

Description

Sleep time divided by total time available for sleep

Time Frame

1 Night

Title

Sleep Latency-Wake After Sleep Onset Time

Description

Time awake in minutes after initial sleep onset

Time Frame

1 Night

Title

Total Sleep Time Spent in Each Sleep Stage

Description

Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)

Time Frame

1 Night

Title

Number of Respiratory Event Related Arousals/ Hour

Description

Total number of respiratory event related arousals/hr over the entire sleep period

Time Frame

1 Night

Title

Number of Spontaneous Arousals/Hour

Description

Number of spontaneous arousals/hr occurring over the entire total sleep time

Time Frame

1 Night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Subject has ability to provide written informed consent Subject aged ≥18 years old Subject has a diagnosis of COPD, OHS or NMD with sleep hypoventilation (historical PtCO2 increase overnight ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg) Subject is currently using non-invasive ventilation for ≥ 3 months Subject with an AHI ≥ 5 hr. (as documented in diagnostic or pressure determination sleep study report) Exclusion Criteria Subjects not compliant on NIV (ie. < 4 hr/night) Subjects with severe asthma Subjects who are pregnant Subjects on oxygen therapy (ie. >4 L/min) Subjects with a tracheostomy Subjects who are acutely ill, medically complicated or who are medically unstable Subjects in whom PAP therapy is otherwise medically contraindicated Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome. Subjects who require ventilatory support during wakefulness Subjects with the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, low blood pressure, cerebrospinal fluid leak, recent cranial surgery or trauma. Subjects with severe developmental delay and who will not be able to follow tasks as instructed in the protocol. Subjects who the investigator believes are unsuitable for inclusion because either: they do not comprehend English they are unable or unwilling to provide written informed consent they are physically unable to comply with the protocol they are unsuitable to participate in the trial for any other reason in the opinion of the investigator

Facility Information:

Facility Name

Sir Charles Gairdner Hospital

City

Perth

State/Province

Western Australia

Country

Australia

Facility Name

University of Western Australia

City

Perth

State/Province

Western Australia

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Juno Perth Clinical Trial

We'll reach out to this number within 24 hrs