Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001372774
Ethics application status
Approved
Date submitted
4/12/2013
Date registered
13/12/2013
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Date results provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Do sleep studies improve outcomes for patients with respiratory failure who need to use long-term non-invasive ventilation?
Scientific title
In individuals with chronic respiratory failure that require non-invasive positive pressure ventilation (NIPPV), does polysomnography titration, compared to clinical titration, improve sleep, physiological and subjective patient-reported outcomes
Secondary ID [1] 283681 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PSG4NIV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic respiratory failure 290640 0
Obesity-hypoventilation syndrome 290641 0
Motor neurone disease 290642 0
Restrictive thoracic disease 290643 0
Neuromuscular disease 290644 0
Condition category
Condition code
Respiratory 291024 291024 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinical titration of NIPPV settings using daytime monitoring techniques (such as pulse oximetry, clinical assessment and daytime arterial blood gases where required). These will be performed by an experienced respiratory physiotherapist under the supervision of a respiratory/sleep physician. Clinical titration will occur during daylight hours (over typically 2-4hrs) on a single occasion. After an acclimatisation period (2 weeks), those in the intervention group will undergo a single night in-lab attended polysomnography titration of non-invasive positive pressure ventilation (NIPPV). These will be performed and supervised by a sleep scientist and settings will be adjusted to optimise pulse oximetry, reduce hypoventilation and improve synchrony between the patient and the device. Optimised settings will subsequently be determined by a sleep physician experienced in the use of NIPPV and interpretation of polysomnography studies. Participants will continue to use NIPPV every night as prescribed before returning after 6 weeks for a PSG and repeat measures.
Intervention code [1] 288379 0
Treatment: Other
Comparator / control treatment
Clinical titration of NIPPV settings using daytime monitoring techniques (such as pulse oximetry, clinical assessment and daytime arterial blood gases where required). These will be performed by an experienced respiratory physiotherapist under the supervision of a respiratory/sleep physician. Clinical titration will occur during daylight hours (over typically 2-4hrs) on a single occasion. After an acclimatisation period (2 weeks), those in the control group will undergo a single night in-lab attended polysomnography (PSG) but without titration of non-invasive positive pressure ventilation (NIPPV) (ie a 'sham' PSG titration). Those in the control arm will retain their original settings after the sham PSG. Participants will continue to use NIPPV every night as prescribed before returning after 6 weeks for a PSG and repeat measures.
Control group
Active

Outcomes
Primary outcome [1] 291011 0
Asynchrony index (from polysomnography (PSG))
Timepoint [1] 291011 0
6 weeks
Primary outcome [2] 291012 0
Arousal index (from PSG)
Timepoint [2] 291012 0
6 weeks
Secondary outcome [1] 305827 0
Oxygen desaturation index, SpO2 nadir, Time SpO2<90% (from PSG)
Timepoint [1] 305827 0
6 weeks
Secondary outcome [2] 305828 0
Total Sleep Time (from PSG)
Timepoint [2] 305828 0
6 weeks
Secondary outcome [3] 305829 0
Change in Daytime PaCO2 (from arterial blood gas)
Timepoint [3] 305829 0
6 weeks
Secondary outcome [4] 305830 0
Adherence (average hours use per night - measured from stored data on the device)
Timepoint [4] 305830 0
6 weeks
Secondary outcome [5] 305831 0
Intolerance rate (cessation of therapy +/- suboptimal adherence)
Timepoint [5] 305831 0
6 weeks
Secondary outcome [6] 305832 0
% REM Sleep and % Slow Wave Sleep (from PSG)
Timepoint [6] 305832 0
6 weeks
Secondary outcome [7] 305833 0
Change in Modified Borg Dyspnoea Scale
Timepoint [7] 305833 0
6 weeks
Secondary outcome [8] 305834 0
Change in AQoL 8D (generic health-related quality of life (HRQoL) instrument)
Timepoint [8] 305834 0
6 weeks
Secondary outcome [9] 305835 0
Change in SRI (disease specific HRQoL instrument0
Timepoint [9] 305835 0
6 weeks
Secondary outcome [10] 305836 0
Change in PSQI (sleep quality instrument)
Timepoint [10] 305836 0
6 weeks
Secondary outcome [11] 305837 0
Change in KSS and ESS (somnolence measures)
Timepoint [11] 305837 0
6 weeks
Secondary outcome [12] 305838 0
Change in FSS (fatigue instrument)
Timepoint [12] 305838 0
6 weeks
Secondary outcome [13] 305839 0
Sleep efficiency (from PSG)
Timepoint [13] 305839 0
6 weeks
Secondary outcome [14] 305840 0
Change in activity levels, sleep duration (measured using Actigraphy)
Timepoint [14] 305840 0
6 weeks
Secondary outcome [15] 305841 0
Early costs (health care contacts, admissions, equipment)
Timepoint [15] 305841 0
6 weeks

Eligibility
Key inclusion criteria
Medically stable
Suitable for elective (outpatient) implementation of NIPPV
Clinical indication to commence long term NIPPV according to local protocols, published guidelines or specialist opinion
Confirmed clinical diagnosis of underlying cause of respiratory failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypoventilation attributable to medications with sedative/respiratory depressant effects
Previous use of NIPPV for more than 1 month in the previous 3 months
Not proficient in English
Inability to provide informed consent
Previous intolerance of NIPPV
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be performed completely separately from recruitment and will be concealed through the use of sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised sequence will be computer generated. We will use a randomised block design with diagnostic group as the blocking variable.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 32 (16 per group) would have 80% power (alpha = 0.05) to detect a 50% reduction in asynchrony index and a 70% in oxygen-desaturation index based on previous studies. We intend to recruit 36 participants to our pilot study which will allow a 10% drop-out rate. We intend to extend the study to recruit 110 participants to allow subgroup analyses. We plan to perform two-way ANOVA and multiple regression analysis. A priori subgroups have been identified and include our diagnostic groups (ALS/MND, OHS, Other), those with severe bulbar symptoms, and those with early (prior to PSG) poor adherence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/12/2013
Actual
17/12/2013
Date of last participant enrolment
Anticipated
1/06/2015
Actual
30/12/2015
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
110
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1785 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 7599 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 288368 0
Self funded/Unfunded
Name [1] 288368 0
Country [1] 288368 0
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
145 Studley Road
PO Box 5555
Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 287073 0
None
Name [1] 287073 0
Address [1] 287073 0
Country [1] 287073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290255 0
Austin Health - Human Research Ethics Committee
Ethics committee address [1] 290255 0
Ethics committee country [1] 290255 0
Australia
Date submitted for ethics approval [1] 290255 0
Approval date [1] 290255 0
10/09/2013
Ethics approval number [1] 290255 0
05115

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44678 0
Dr Mark Howard
Address 44678 0
C/o Institute for Breathing and Sleep
Austin Hospital
PO Box 5555
Heidelberg, VIC 3084
Country 44678 0
Australia
Phone 44678 0
+61394965390
Fax 44678 0
+61394965124
Email 44678 0
[email protected]
Contact person for public queries
Name 44679 0
Liam Hannan
Address 44679 0
C/o Institute for Breathing and Sleep
Austin Hospital
PO Box 5555
Heidelberg, VIC 3084
Country 44679 0
Australia
Phone 44679 0
+61394965390
Fax 44679 0
+61394965124
Email 44679 0
[email protected]
Contact person for scientific queries
Name 44680 0
Liam Hannan
Address 44680 0
C/o Institute for Breathing and Sleep
Austin Hospital
PO Box 5555
Heidelberg, VIC 3084
Country 44680 0
Australia
Phone 44680 0
+61394965390
Fax 44680 0
+61394965124
Email 44680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Full dataset in de-identified form
When will data be available (start and end dates)?
For 5 years from study completion
Available to whom?
Researchers on request to corresponding author
Available for what types of analyses?
Systematic review/meta-analyses
How or where can data be obtained?
By contacting the corresponding author


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.