Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000087651
Ethics application status
Not required
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of circadian disruption and sleep deprivation in respiratory disorders
Scientific title
Effects of sleep deprivation on neurobehavioural and physiological variables in patients with respiratory disorders and healthy controls.
Secondary ID [1] 296719 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 166 0
Asthma 167 0
Condition category
Condition code
Respiratory 186 186 0 0
Sleep apnoea
Respiratory 187 187 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine the effect of sleep restriction (4 nights with 4 hours time in bed for sleep allowed) on a range of neurobehavioural and physiological variables in patients with obstructive sleep apnea or asthma.
Intervention code [1] 86 0
None
Comparator / control treatment
Healthy control subjects.
Control group
Active

Outcomes
Primary outcome [1] 223 0
The total number of lapses (defined as RT> 500ms) during a 10-min psychomotor vigilance task (PVT)
Timepoint [1] 223 0
Primary outcome [2] 224 0
Mean slowest 10% metric of the PVT during a 10-min psychomotor vigilance task (PVT)
Timepoint [2] 224 0
Primary outcome [3] 225 0
Subjective sleepiness as determined by the KSS
Timepoint [3] 225 0
Primary outcome [4] 226 0
Changes in Rsr and expired NO, and changes in RDI and sleep architecture during the period of sleep restriction, compared to baseline values in patients and to effects in healthy control subjects during the sleep restriction period.
Timepoint [4] 226 0
Secondary outcome [1] 510 0
Other measures of neurocognitive functioning, including working memory function, cognitive throughput, arithmetic and time estimation.
Timepoint [1] 510 0
Secondary outcome [2] 511 0
Other measures of subjective alertness and functioning capabilities.
Timepoint [2] 511 0
Secondary outcome [3] 512 0
Core body temperature for circadian phase assessments.
Timepoint [3] 512 0
Secondary outcome [4] 513 0
Objective levels of alertness measuring using the waking EEG.
Timepoint [4] 513 0

Eligibility
Key inclusion criteria
OSA: Untreated subjects with moderate to severe OSA (RDI > 30).
Asthma: Asthmatic subjects (ATS Criteria) will be recruited from asthma clinics associated with AIs. We will use clinic patients (current non-smokers and minimal smoking history)with moderate to severe asthma based on NAC guidelines i.e. those requiring short acting beta agonists 3 or more days week or with nocturnal symptoms more than once per fortnight.
Controls: We will recruit healthy controls.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
OSA: use of alcohol> 40gm/day, psychotropic medication, intercurrent asthma, other unstable medical conditions or evidence of clinically significant awake respiratory failure.
Asthma:We will exclude subjects on long-acting bronchodilators (salmeterol, formoterol, tiotropium and theophylline). Inhaled corticosteroids will be held constant from screening into studies and use of short acting beta agonists will be permitted and monitored during protocols.
Controls: similar exclusion criteria as for the OSA and asthma subjects
Subjects with the presence of asthma (ATS criteria) and OSA will be excluded. The absence of OSA will be determined using a validated nocturnal respiratory monitor over 2 nights (Autoset T, ResMed).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 242 0
Government body
Name [1] 242 0
National Health & Medical Research Council (NHMRC) project funding
Country [1] 242 0
Australia
Funding source category [2] 243 0
Government body
Name [2] 243 0
NHMRC fellowship
Country [2] 243 0
Australia
Funding source category [3] 244 0
Government body
Name [3] 244 0
NSW BioFirst Award
Country [3] 244 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 180 0
University
Name [1] 180 0
University of Sydney
Address [1] 180 0
Country [1] 180 0
Australia
Secondary sponsor category [2] 181 0
Hospital
Name [2] 181 0
Royal Prince Alfred Hospital
Address [2] 181 0
Country [2] 181 0
Australia

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 1040 0
Sydney South West Area Health Services Ethics Review Committee
Ethics committee address [1] 1040 0
Ethics committee country [1] 1040 0
Australia
Date submitted for ethics approval [1] 1040 0
Approval date [1] 1040 0
Ethics approval number [1] 1040 0
Ethics committee name [2] 1041 0
University of Sydney Human Research Ethics Committee
Ethics committee address [2] 1041 0
Ethics committee country [2] 1041 0
Australia
Date submitted for ethics approval [2] 1041 0
Approval date [2] 1041 0
Ethics approval number [2] 1041 0

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

Contacts
Principal investigator
Name 35842 0
Address 35842 0
Country 35842 0
Phone 35842 0
Fax 35842 0
Email 35842 0
Contact person for public queries
Name 9275 0
Ms Wendy Taylor
Address 9275 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9275 0
Australia
Phone 9275 0
+61 2 95156578
Fax 9275 0
+61 2 95505865
Email 9275 0
volunteers@woolcock.org.au
Contact person for scientific queries
Name 203 0
Dr Naomi Rogers
Address 203 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 203 0
Australia
Phone 203 0
+61 2 93510906
Fax 203 0
+61 2 93510914
Email 203 0
nrogers@med.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.