Juno Perth Clinical Trial

NCT ID: NCT02317042

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-29
• Study Completion Date: 2015-11-29

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Juno

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Juno

Intervention Type: DEVICE

Juno device set to AutoEPAP iVAPS mode.

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.

Group Type: ACTIVE_COMPARATOR

Juno

Intervention Type: DEVICE

Juno device set to Fixed EPAP iVAPS mode.

Interventions

Juno

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

Intervention Type: DEVICE

Juno

Juno device set to AutoEPAP iVAPS mode.

Intervention Type: DEVICE

Juno

Juno device set to Fixed EPAP iVAPS mode.

Intervention Type: DEVICE

Other Intervention Names

ResMed "Juno" Device; ResMed "Juno" Device; ResMed "Juno" Device

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Charles Gairdner Hospital

OTHER

Sponsor Role: collaborator

The University of Western Australia

OTHER

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

University of Western Australia

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

MA250814

Identifier Type: -

Identifier Source: org_study_id