Juno Perth Clinical Trial

NCT02317042 | Terminated Results

• 1 other identifier: MA250814
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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)".

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Oxygen Desaturation Index

  1 night

• Mean Oxygen Saturation

  1 night

• Time Spent Below 90% Oxygen Saturation

  1 night

• Mean Transcutaneous Carbon Dioxide (PtcCo2)

  1 night

• Sleep Duration

  1 Night

Study Arms (3)

Standard ST Mode

ACTIVE COMPARATOR

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

AutoEPAP iVAPS

EXPERIMENTAL

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

Fixed EPAP iVAPS

ACTIVE COMPARATOR

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

Interventions

Juno DEVICE

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

Also known as: ResMed "Juno" Device

Standard ST Mode

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• they do not comprehend English
• they are unable or unwilling to provide written informed consent
• they are physically unable to comply with the protocol

Sponsors & Collaborators

• ResMed: lead
• Sir Charles Gairdner Hospital: collaborator
• The University of Western Australia: collaborator

Study Sites (2)

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Location

University of Western Australia

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Obesity Hypoventilation Syndrome; Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Airway Obstruction

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Hypoventilation; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof Nigel McArdle & Prof Peter Eastwood
• Organization: University of Western Australia

peter.eastwood@health.wa.gov.au

+61 8 9346 1706

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 15, 2014
• Study Start: May 29, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 29, 2015
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)