Juno Perth Clinical Trial

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02317042
• Other study ID #: MA250814
• Status: Terminated
• Phase: N/A
• Start date: May 29, 2015
• Est. completion date: November 29, 2015

Study information

• Verified date: May 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)".

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 29, 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Juno
Juno device set to ST mode with participant's current therapy settings.
• Juno
Juno device set to AutoEPAP iVAPS mode.
• Juno
Juno device set to Fixed EPAP iVAPS mode.

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	University of Western Australia	Perth	Western Australia

Sponsors (3)

Lead Sponsor	Collaborator
ResMed	Sir Charles Gairdner Hospital, The University of Western Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oxygen Desaturation Index	Number of oxygen desaturations per hour of sleep	1 night
Secondary	Mean Oxygen Saturation	Mean oxygen saturation recorded in the total sleep time	1 night
Secondary	Time Spent Below 90% Oxygen Saturation	Time in minutes that the oxygen saturation was below 90%	1 night
Secondary	Mean Transcutaneous Carbon Dioxide (PtcCo2)	Transcutaneous Carbon Dioxide measurement (TcCO2)	1 night
Secondary	Sleep Duration	Time spent asleep	1 Night
Secondary	Sleep Efficacy	Sleep time divided by total time available for sleep	1 Night
Secondary	Sleep Latency-Wake After Sleep Onset Time	Time awake in minutes after initial sleep onset	1 Night
Secondary	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
Secondary	Number of Respiratory Event Related Arousals/ Hour	Total number of respiratory event related arousals/hr over the entire sleep period	1 Night
Secondary	Number of Spontaneous Arousals/Hour	Number of spontaneous arousals/hr occurring over the entire total sleep time	1 Night