Juno Perth Clinical Trial

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

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)".

Study Overview

• Status: Terminated
• Conditions: Respiratory Insufficiency; Chronic Obstructive Pulmonary Disease (COPD); Obesity Hypoventilation Syndrome; Neuromuscular Disease; Upper Airway Obstruction
• Intervention / Treatment: Device: Juno; Device: Juno; Device: Juno

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia
      • Sir Charles Gairdner Hospital
    • Perth, Western Australia, Australia
      • University of Western Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard ST Mode; 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.	Device: Juno; Juno device set to ST mode with participant's current therapy settings.; Other Names: ResMed "Juno" Device; Device: Juno; Juno device set to AutoEPAP iVAPS mode.; Other Names: ResMed "Juno" Device; Device: Juno; Juno device set to Fixed EPAP iVAPS mode.; Other Names: ResMed "Juno" Device
Experimental: AutoEPAP iVAPS; 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.	Device: Juno; Juno device set to ST mode with participant's current therapy settings.; Other Names: ResMed "Juno" Device; Device: Juno; Juno device set to AutoEPAP iVAPS mode.; Other Names: ResMed "Juno" Device; Device: Juno; Juno device set to Fixed EPAP iVAPS mode.; Other Names: ResMed "Juno" Device
Active Comparator: Fixed EPAP iVAPS; 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.	Device: Juno; Juno device set to ST mode with participant's current therapy settings.; Other Names: ResMed "Juno" Device; Device: Juno; Juno device set to AutoEPAP iVAPS mode.; Other Names: ResMed "Juno" Device; Device: Juno; Juno device set to Fixed EPAP iVAPS mode.; Other Names: ResMed "Juno" Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnoea-Hypopnoea Index (AHI)	The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS	1 night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Desaturation Index	Number of oxygen desaturations per hour of sleep	1 night
Mean Oxygen Saturation	Mean oxygen saturation recorded in the total sleep time	1 night
Time Spent Below 90% Oxygen Saturation	Time in minutes that the oxygen saturation was below 90%	1 night
Mean Transcutaneous Carbon Dioxide (PtcCo2)	Transcutaneous Carbon Dioxide measurement (TcCO2)	1 night
Sleep Duration	Time spent asleep	1 Night
Sleep Efficacy	Sleep time divided by total time available for sleep	1 Night
Sleep Latency-Wake After Sleep Onset Time	Time awake in minutes after initial sleep onset	1 Night
Total Sleep Time Spent in Each Sleep Stage	Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)	1 Night
Number of Respiratory Event Related Arousals/ Hour	Total number of respiratory event related arousals/hr over the entire sleep period	1 Night
Number of Spontaneous Arousals/Hour	Number of spontaneous arousals/hr occurring over the entire total sleep time	1 Night

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: The University of Western Australia; Sir Charles Gairdner Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 29, 2015

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Airway Obstruction; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• Other Study ID Numbers: MA250814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No