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Trial registered on ANZCTR


Registration number
ACTRN12616000454471
Ethics application status
Approved
Date submitted
31/03/2016
Date registered
7/04/2016
Date last updated
4/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Neurocognitive function, sleep and well-being in patients with Cystic Fibrosis with mild lung
disease
Scientific title
Neurocognitive function, sleep and well-being in patients with Cystic Fibrosis with mild lung
disease
Secondary ID [1] 288887 0
Nil known
Universal Trial Number (UTN)
U1111-1181-4264
Trial acronym
-
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 298189 0
Condition category
Condition code
Respiratory 298351 298351 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 298377 298377 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients (CF and non-CF Controls) will be asked to complete the following at baseline, during and after an respiratory exacerbation/worsening.
1. CF and Sleep related questionnaires (Duration: 1/2 hour)
2. Oxygen (Duration: 3 nights) and Activity home monitoring (Duration: 7 days) watches
3. Sleep study (Duration: 1 night)
4. Neurocognitive testing battery on a computer (Duration: 2 hours)
5. Blood tests (part of routine care)

Testing during and after an exacerbation applies to CF patients. Post exacerbation testing will be performed 4 weeks post recovery.

Non CF controls will be invited to perform testing during a baseline visit and in the same time frame of an exacerbation for the matched CF participant (within 4-6 weeks).

Patients will be monitored for their first exacerbation over the 21 month trial duration period.
Intervention code [1] 294344 0
Not applicable
Comparator / control treatment
Non-CF control subjects will be age and education matched and will be invited to perform similar tests (see above).

Testing will occur during a baseline visit and in the same time frame of an exacerbation for the matched CF participant (within 4-6 weeks).
Control group
Active

Outcomes
Primary outcome [1] 297824 0
Psychomotor vigilance test (PVT) - reaction time (ms)
Timepoint [1] 297824 0
Compare PVT results at baseline, during and after a lung exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [1] 322347 0
N-Back 1 and 2 - working memory
Timepoint [1] 322347 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [2] 322434 0
Stroop Test - capacity to direct attention
Timepoint [2] 322434 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [3] 322435 0
Tower of London - executive function assessment
Timepoint [3] 322435 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [4] 322436 0
Cystic Fibrosis Questionnaire - Quality of LIfe assessment
Timepoint [4] 322436 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [5] 322437 0
PHQ-9: Mood assessment
Timepoint [5] 322437 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [6] 322438 0
GAD-7: Anxiety assessment
Timepoint [6] 322438 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [7] 322439 0
Insomnia severity index - outcome measure for insomnia
Timepoint [7] 322439 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [8] 322440 0
Epworth Sleepiness Score - measure of level of sleepiness
Timepoint [8] 322440 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [9] 322441 0
Markers of inflammation - C-reactive protein, Interleukin-6, Interleukin-10, full blood count,
Timepoint [9] 322441 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [10] 322442 0
Nocturnal oxygen monitoring - measure of hypoxemia during sleep. This will be assessed using an oxymetry watch/device which is worn just before bed and removed upon awakening for 3 consecutive nights.
Timepoint [10] 322442 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.
Secondary outcome [11] 322443 0
Activity monitoring - for assessment of circadian rhythm and activity level. This will be measured using an Actiwatch device, which is worn on the wrist for 7 days.
Timepoint [11] 322443 0
Test results will be compared at baseline, during and after an exacerbation. Post exacerbation testing will occur 4 weeks post recovery.

Eligibility
Key inclusion criteria
CF Inclusion criteria
* FEV1 70 - 89%
* Stable lung function (see exclusion criteria)

Non CF healthy controls inclusion criteria
* Matched for age and education to CF participant
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
CF Patient Exclusion criteria
* Uncontrolled medical conditions
* Prescribed intravenous or oral antibiotics for CF exacerbation in the past 8 weeks
* Patients with Burkholderia cepacia and non tuberculous mycobacteria
* Prior lung transplant
* Not proficient in English
* Inability to provide informed consent

Non-CF control exclusion criteria:
* Uncontrolled medical conditions
* Acute medical conditions - eg. active lung infection
* Not proficient in English

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
CF patients will be compared with an age and education matched non-CF control group with respect to the sleep and cognitive outcomes tested (primary outcome is the PVT) using linear regression modelling. The effect of group will be examined, controlling for BMI, age, and years of education. Response to treatment of CF exacerbations (mean change with 95% confidence limits) will be assessed by paired-t-test, and also by mixed effects modelling to control for changes in oxygen saturation on the change in performance.

A total of 30 CF patients will be studied. This will provide 80% power to detect a 0.531ms difference in response times between the two groups (assume SD=0.5ms, alpha 0.05, controlling for circadian effects). Allowing for 20% loss to follow-up, the sample is powered to detect a 0.6ms change in response times (at 80% power, within subject SD=0.5ms). A total of 30 non-CF controls will also be studied.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
18/04/2016
Actual
18/04/2016
Date of last participant enrolment
Anticipated
8/01/2018
Actual
12/08/2016
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
60
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5523 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 12993 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 293239 0
Hospital
Name [1] 293239 0
Royal Prince Alfred Hospital
Country [1] 293239 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown 2050 NSW
Country
Australia
Secondary sponsor category [1] 292038 0
None
Name [1] 292038 0
None
Address [1] 292038 0
N/A
Country [1] 292038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294717 0
Sydney Local Health District
Ethics committee address [1] 294717 0
Royal Prince Alfred Hospital
Research Ethics and Governance Office
Camperdown NSW 2050
Ethics committee country [1] 294717 0
Australia
Date submitted for ethics approval [1] 294717 0
18/01/2016
Approval date [1] 294717 0
10/02/2016
Ethics approval number [1] 294717 0

Summary
Brief summary
This will be an observational study in CF patients with mild lung disease, examining the relationship between neurocognitive function and sleep parameters. Additional factors to be studied include hypoxemia, inflammatory markers, circadian rhythm and mood.

CF participants will be tested at baseline, during and after lung exacerbation. Age and education matched non-CF controls will be invited to participate as well.

Summary of tests to be performed at each visit:
1. Sleep study with high density EEG
2. Blood tests
3. Activity and oxygen monitoring with watches
4. Neurocognitive tests and Questionnaires.
Trial website
Nil.
Trial related presentations / publications
Nil.
Public notes
Nil.

Contacts
Principal investigator
Name 64802 0
Dr Sheila Sivam
Address 64802 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 64802 0
Australia
Phone 64802 0
+612 9515 8195
Fax 64802 0
+612 9515 8196
Email 64802 0
[email protected]
Contact person for public queries
Name 64803 0
Sheila Sivam
Address 64803 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 64803 0
Australia
Phone 64803 0
+612 9515 8195
Fax 64803 0
+612 9515 8196
Email 64803 0
[email protected]
Contact person for scientific queries
Name 64804 0
Sheila Sivam
Address 64804 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 64804 0
Australia
Phone 64804 0
+612 9515 8195
Fax 64804 0
+612 9515 8196
Email 64804 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.