Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000415606
Ethics application status
Approved
Date submitted
11/09/2005
Date registered
15/09/2005
Date last updated
4/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of inspiratory duration and chinstrap during non-invasive ventilation
Scientific title
The effect of inspiratory duration and chinstrap during non-invasive ventilation: Effects on sleep quality and gas exchange in subjects with nocturnal hypoventilation
Universal Trial Number (UTN)
Trial acronym
Ti Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nocturnal hypoventilation 523 0
Hypercapnic Respiratory Failure 524 0
Condition category
Condition code
Respiratory 604 604 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Night 1: Sleep study titration review study on non-invasive ventilation (with titration of inspiratory time during the study and no chinstrap).

Nights 2,3 & 4 at home acclimatizing to NIV without chinstrap. (inspiratory duration not set)

Night 5, 6 & 7: Three experimental nights in randomized order
Inspiratory duration set no chinstrap
Inspiratory duration not set no chinstrap
Inspiratory duration set with chinstrap

The duration on the experimental interventions is one night each.
Intervention code [1] 456 0
None
Comparator / control treatment
The inspiratory duration not set no chinstrap night serves as the control.
Control group
Active

Outcomes
Primary outcome [1] 699 0
Sleep quality including sleep efficiency
Timepoint [1] 699 0
Measured during the three experimental nights (5, 6, 7)
Primary outcome [2] 700 0
Sleep quality including arousals
Timepoint [2] 700 0
Measured during the three experimental nights (5, 6, 7)
Primary outcome [3] 701 0
Sleep quality including percentage REM sleep
Timepoint [3] 701 0
Measured during the three experimental nights (5, 6, 7)
Secondary outcome [1] 1437 0
1. Non-invasive gas exchange overnight (SaO2, TcCO2).
Timepoint [1] 1437 0
Measured during the experimental nights.
Secondary outcome [2] 1438 0
2. Apnoea and arousal index.
Timepoint [2] 1438 0
Measured during the experimental nights.
Secondary outcome [3] 1439 0
3. Subjective scores of comfort and sleep.
Timepoint [3] 1439 0
Assessed on the morning following experimental nights.
Secondary outcome [4] 1440 0
4. Synchronization index (number of successful inspiratory and expiratory triggers).
Timepoint [4] 1440 0
Measured on experimental nights.
Secondary outcome [5] 1441 0
5. Psychomotor vigilance testing.
Timepoint [5] 1441 0
Measured on the mornimgs at approximately 8am following each experimental night.

Eligibility
Key inclusion criteria
Patients with documented nocturnal hypoventilation from any cause. Using non-invasive ventilation chronically at home. Be using a bilevel pressure preset ventilator at home in the spontaneous mode. Be using a nasal interface with NIV. Preferably to be using NIV without the use of supplemental oxygen. To be included in the study, subjects will: 1. Have to have sustained improvements in gas exchange and symptomatolgy. 2. Be compliant with non-invasive ventilation at home (using >5hrs per night). 3. Able to attend the sleep laboratory on 3 nights within the trial period (ie 6 nights).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded from the study where: 1. Their is limited upper limb movement which would prevent or limit the removal of the nasal mask. 2. Significant psychiatric or psychological conditions exist which are likely to prevent accurate reporting in regard to the comfort of therapy. 3. A history of acute respiratory illness within the last month. 4. The taking of any hypnotic or anti-depressant medication.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence generator (www.randomization.com)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 660 0
Commercial sector/Industry
Name [1] 660 0
ResMed Ltd
Country [1] 660 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Ltd
Address
Country
Australia
Secondary sponsor category [1] 550 0
Commercial sector/Industry
Name [1] 550 0
ResMed Ltd
Address [1] 550 0
Country [1] 550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1799 0
Central Sydney Health Service Ethics Review Committee
Ethics committee address [1] 1799 0
Ethics committee country [1] 1799 0
Australia
Date submitted for ethics approval [1] 1799 0
Approval date [1] 1799 0
Ethics approval number [1] 1799 0

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

Contacts
Principal investigator
Name 35121 0
Address 35121 0
Country 35121 0
Phone 35121 0
Fax 35121 0
Email 35121 0
Contact person for public queries
Name 9645 0
Ms Wendy Taylor
Address 9645 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9645 0
Australia
Phone 9645 0
+61 2 95156578
Fax 9645 0
+61 2 95505865
Email 9645 0
[email protected]
Contact person for scientific queries
Name 573 0
Dr Grant Willson
Address 573 0
C/- Sleep Investigations Unit
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 573 0
Australia
Phone 573 0
+61 2 95158708
Fax 573 0
+61 2 95157196
Email 573 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

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Willson, G.N., Piper, A.J., Norman, M., Chaseling,... [More Details]

Documents added automatically
No additional documents have been identified.