Clinical trial NCT02317042: Juno Perth Clinical Trial
Official title: The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Insufficiency
Obesity Hypoventilation Syndrome
Chronic Obstructive Pulmonary Disease (COPD)
Neuromuscular Disease
Upper Airway Obstruction
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Sir Charles Gairdner Hospital
name: The University of Western Australia
First posted: 2014-12-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Apnoea-Hypopnoea Index (AHI)
timeFrame: 1 night
Secondary outcomes:
measure: Oxygen Desaturation Index
timeFrame: 1 night
measure: Mean Oxygen Saturation
timeFrame: 1 night
measure: Time Spent Below 90% Oxygen Saturation
timeFrame: 1 night
measure: Mean Transcutaneous Carbon Dioxide (PtcCo2)
timeFrame: 1 night
measure: Sleep Duration
timeFrame: 1 Night
measure: Sleep Efficacy
timeFrame: 1 Night
measure: Sleep Latency-Wake After Sleep Onset Time
timeFrame: 1 Night
measure: Total Sleep Time Spent in Each Sleep Stage
timeFrame: 1 Night
measure: Number of Respiratory Event Related Arousals/ Hour
timeFrame: 1 Night
measure: Number of Spontaneous Arousals/Hour
timeFrame: 1 Night
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: University of Western Australia
state: Western Australia
Study officials:
References: