Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001286932
Ethics application status
Approved
Date submitted
28/11/2011
Date registered
15/12/2011
Date last updated
2/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving sleep and quality of life in patients with idiopathic interstitial pneumonia, using nocturnal supplemental oxygen
Scientific title
In patients with idiopathic interstitial pneumonia, nocturnal supplemental oxygen compared with placebo, improves sleep and quality of life
Secondary ID [1] 273482 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic interstitial pneumonia 279272 0
Interstitial lung disease 309122 0
Condition category
Condition code
Respiratory 279470 279470 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxygen (2 litres/min) via nasal cannulae from a concentrator during sleep (approximately 6 to 8 hours per 24 hours), every night for 4 weeks, with an overnight sleep study on day 28.

Subjects then have a two week washout period and crossover to receive the sham intervention, as below, for a further 4 weeks, and then another sleep study on day 70.
Note: the order of these two arms will be random so as to ensure blinding for subjects and investigators.
Intervention code [1] 283800 0
Treatment: Other
Comparator / control treatment
Air (2 litres/min) via the same route as intervention
Control group
Placebo

Outcomes
Primary outcome [1] 286035 0
The primary outcome in this study is the total sleep time with SpO2 below 90%.
Timepoint [1] 286035 0
Day 0, Day 29 (after 1st intervention/ sleep study), Day 71 (after 2nd intervention/ sleep study)
Secondary outcome [1] 295241 0
Quality of life questionnaire: St George's Respiratory Questionnaire
Timepoint [1] 295241 0
Day 0, Day 29 (after 1st intervention), Day 71 (after 2nd intervention)
Secondary outcome [2] 295242 0
Quality of life questionnaire: University of California, San Diego Shortness of Breath Questionnaire
Timepoint [2] 295242 0
Day 0, Day 29 (after 1st intervention/ sleep study), Day 71 (after 2nd intervention/ sleep study)
Secondary outcome [3] 295243 0
Pittsburgh Sleep Quality Index
Timepoint [3] 295243 0
Day 0, Day 29 (after 1st intervention/ sleep study), Day 71 (after 2nd intervention/ sleep study)
Secondary outcome [4] 295244 0
Apnoea-Hypopnoea Index
Timepoint [4] 295244 0
Baseline sleep study, Day 28 sleep study, Day 70 sleep study
Secondary outcome [5] 295245 0
Arousal index
Timepoint [5] 295245 0
Baseline sleep study, Day 28 sleep study, Day 70 sleep study
Secondary outcome [6] 295246 0
Oxygen desaturation index
Timepoint [6] 295246 0
Baseline sleep study, Day 28 sleep study, Day 70 sleep study
Secondary outcome [7] 295247 0
Sleep architecture (% slow wave, REM and transitional sleep)
Timepoint [7] 295247 0
Baseline sleep study, Day 28 sleep study, Day 70 sleep study
Secondary outcome [8] 295255 0
Differences in Six minute walk distance (measured in metres)
Timepoint [8] 295255 0
Day 0, Day 29 and Day 71

Eligibility
Key inclusion criteria
Patients 18 - 80 yrs.
Patients able to perform a polysomnogram (sleep study), as determined following clinical assessment.
Patients with nocturnal hypoxaemia, defined as >10% of the night with SpO2 <90% on overnight oximetry or PSG
Patients able to give informed consent.
Patients with idiopathic interstitial pneumonia (IIP), according to American Thoracic Society /European Respiratory Society criteria.
Absence of daytime resting hypoxaemia (ie with PaO2 > 55mmHg).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients <18yrs or >80yrs.
Patients not able to give informed consent.
Patients considered unable to complete a PSG by their physician.
Presence of daytime resting hypoxaemia (PaO2 less than or equal to 55mmHg).
Presence of hypercapnia (PaCO2 > 45mmHg) at baseline
Patients who do not meet oxygen saturation criteria for nocturnal hypoxaemia
Patients with co-existent obstructive sleep apnoea with apnoea hypopnoea index greater than or equal to 15 with clinical symptoms, or apnoea hypopnoea index greater than or equal to 30 (without symptoms)
Patients who are current smokers

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enrolled following assessment at an outpatient Interstitial Lung Disease clinic for suitability, and informed consent.

Allocation will be concealed, and will be performed using sequential sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment will be allocated randomly via a computer randomised permuted block sequence with a variable block size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2012
Actual
27/07/2012
Date of last participant enrolment
Anticipated
Actual
29/07/2015
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
30
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284274 0
Hospital
Name [1] 284274 0
Royal Prince Alfred Hospital
Country [1] 284274 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 283225 0
None
Name [1] 283225 0
Address [1] 283225 0
Country [1] 283225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286234 0
Royal Prince Alfred Hospital Ethics Review Committee
Ethics committee address [1] 286234 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Ethics committee country [1] 286234 0
Australia
Date submitted for ethics approval [1] 286234 0
09/11/2011
Approval date [1] 286234 0
08/12/2011
Ethics approval number [1] 286234 0
HREC/11/RPAH/510

Summary
Brief summary
This study is aimed at looking at the physiology of sleep in patients with lung fibrosis. Investigators are particularly interested in those people whose oxygen levels fall during sleep, and the role of giving supplemental oxygen in such cases.

The hypothesis is that supplemental oxygen during sleep improves a number of health domains, including quality of life, sleep quality, blood flow in the lungs and strain on the heart.

Subjects will receive oxygen (or air) during sleep via nasal prongs for 4 weeks. They will then undergo an overnight sleep study. After a two-week "washout" period, they will then receive air (or oxygen) through nasal prongs for 4 weeks, followed by another sleep study.
Trial website
Trial related presentations / publications
Abstract/ oral presentation Thoracic Society of Australia and New Zealand 2016: "Supplemental oxygen improves sleep disordered breathing but not quality of life in patients with interstitial lung disease".
Public notes

Contacts
Principal investigator
Name 33450 0
Dr Lauren Troy
Address 33450 0
Department of Respiratory Medicine Royal Prince Alfred Hospital,
155 Missenden Rd Camperdown NSW 2050
Country 33450 0
Australia
Phone 33450 0
+61295158296
Fax 33450 0
+612 95158196
Email 33450 0
[email protected]
Contact person for public queries
Name 16697 0
Dr Lauren Troy
Address 16697 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 16697 0
Australia
Phone 16697 0
+61295156111
Fax 16697 0
Email 16697 0
[email protected]
Contact person for scientific queries
Name 7625 0
Dr Lauren Troy
Address 7625 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 7625 0
Australia
Phone 7625 0
+61295156111
Fax 7625 0
Email 7625 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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