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Trial registered on ANZCTR


Registration number
ACTRN12618000373279p
Ethics application status
Submitted, not yet approved
Date submitted
6/02/2018
Date registered
13/03/2018
Date last updated
13/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of continuous positive airway pressure for seizure control in patient with moderate to severe obstructive sleep apnoea and epilepsy
Scientific title
A prospective, randomised trial of continuous positive airway pressure for seizure control in patient with moderate to severe obstructive sleep apnoea and pharmacoresistant epilepsy
Secondary ID [1] 293128 0
CPAP in Epilepsy
Universal Trial Number (UTN)
U1111-1208-9904
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 305089 0
pharmacoresistant epilepsy 305090 0
Condition category
Condition code
Respiratory 304403 304403 0 0
Sleep apnoea
Neurological 304404 304404 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be treated with continuous positive airway pressure therapy.
This involves the use of a face-mask and pump, supplying room air, overnight. Patients will be asked to use CPAP therapy for a minimum of four hours per night, on seven nights per week. CPAP therapy will be delivered at home, and the pressure, humidity and other settings will be individually adjusted per patient. Patients will be instructed in the use of their machine by the treating clinical team. Compliance with CPAP therapy will be assessed using a digital download from the device at the specified time points within the trial.
Intervention code [1] 299374 0
Treatment: Devices
Comparator / control treatment
Patients will be randomly allocated to early or routine treatment with CPAP therapy. The early intervention group will be offered CPAP therapy at study week 4, and the routine treatment group at study week 16. Comparisons will be made between the early and routine groups. Comparisons will also be made between all patients at baseline and after treatment. Routine treatment is determined by the standard, non-urgent waiting list for the sleep clinic.
Control group
Active

Outcomes
Primary outcome [1] 303640 0
Mean seizure frequency per four week period, as determined by a seizure diary which is to be completed by each participant.
Timepoint [1] 303640 0
The seizure diary will be maintained throughout the trial period. Seizure frequency will be calculated as the mean number of seizure per four week period. Outcomes will be reviewed at baseline considered study week 4, at week 16, and at the end of the trial period.
Secondary outcome [1] 339731 0
Epworth Sleepiness Score
Timepoint [1] 339731 0
At baseline and at 12 weeks after commencing CPAP.
Secondary outcome [2] 339732 0
Pittsburgh Sleep Quality Index
Timepoint [2] 339732 0
At baseline and at 12 weeks after commencing CPAP.
Secondary outcome [3] 339733 0
Hospital anxiety and depression scale.
Timepoint [3] 339733 0
At baseline and at 12 weeks after commencing CPAP.
Secondary outcome [4] 339734 0
Symptom Checklist-90 (SCL-90) is used as a measure of psychological problems.
Timepoint [4] 339734 0
At baseline and at 12 weeks after commencing CPAP.
Secondary outcome [5] 339735 0
Neuropsychiatric Unit Cognitive Assessment Tool
Timepoint [5] 339735 0
At baseline and at 12 weeks after commencing CPAP.
Secondary outcome [6] 339737 0
Quality of Life in Epilepsy (QOLIE-89)
Timepoint [6] 339737 0
At baseline and at 12 weeks after commencing CPAP.
Secondary outcome [7] 339738 0
Serum beta-amyloid.
Timepoint [7] 339738 0
At baseline and at twelve weeks.

Eligibility
Key inclusion criteria
Patients must have a diagnosis of untreated moderate or severe obstructive sleep apnoea on polysomnography.
Patients must have a diagnosis of pharmacoresistant epilepsy on video-electroencephalography.
Patients must tolerate more than four hours of CPAP therapy for 3 nights, in a one week APAP trial, and be willing to continue on CPAP therapy.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not aware of their seizures.
Patients who are already effectively treated for obstructive sleep apnoea, or who refuse CPAP therapy.
Patients who are unable to provide informed consent.

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)
Patients will not be blinded to their treatment allocation. Allocation will be concealed by a schedule maintained at an administrative site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The delayed treatment group will eventually commence on CPAP also.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis shall be conducted using a per protocol analysis and an intention to treat analysis for the primary and secondary end points.
A Mann-Whitney u-test will be used retrospectively to compare all parameters in both groups during phase 0 to ensure that randomisation was successful.
The primary end point of phase I (interim analyses) is 50% responder rate, compared between the early and delayed treatment groups, and determined by Fisher’s Exact test of proportions.
The secondary end points shall also be reviewed in phase I and will be examined using a Mann-Whitney U-test.
The primary end point of phase II is an intra-subject reduction in seizure frequency, and will be made using a Wilcoxon signed-ranks test.
Secondary endpoints will also be intra-subject comparisons of ESS, PSQI, NUCog, QOLIE-89, HADS, and SCL-90 and will also be examined by means of a Wilcoxon signed-ranks test.
Serum betaAmyloid will be compared between the early and late treatment groups by Mann-Whitney U-test, and before and after treatment using a Wilcoxon signed ranks test.
QOLIE-89 scores will be converted into QALY, and used for cost-utility analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2018
Actual
Date of last participant enrolment
Anticipated
5/04/2019
Actual
Date of last data collection
Anticipated
1/10/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9187 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 9675 0
The Alfred - Prahran
Recruitment postcode(s) [1] 17837 0
3050 - Parkville
Recruitment postcode(s) [2] 18440 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 297754 0
Hospital
Name [1] 297754 0
the Royal Melbourne Hospital
Country [1] 297754 0
Australia
Primary sponsor type
Hospital
Name
Department of Neurology, The Alfred Hospital
Address
55 Commercial Road, Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 296791 0
None
Name [1] 296791 0
Address [1] 296791 0
Country [1] 296791 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298816 0
Melbourne Health
Ethics committee address [1] 298816 0
Ethics committee country [1] 298816 0
Australia
Date submitted for ethics approval [1] 298816 0
01/11/2017
Approval date [1] 298816 0
Ethics approval number [1] 298816 0

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

Contacts
Principal investigator
Name 78322 0
Dr Andrew (Andreas) Pattichis
Address 78322 0
The Department of Neurology
The Royal Melbourne Hospital,
300 Grattan Street,
Parkville, 3050,
Victoria
Country 78322 0
Australia
Phone 78322 0
61 3 9342 7000
Fax 78322 0
+61 3 9342 7802
Email 78322 0
andreas.pattichis@mh.org.au
Contact person for public queries
Name 78323 0
andrew (andreas) pattichis
Address 78323 0
the royal Melbourne hospital,
department of neurology,
300 Grattan street,
Parkville, 3050,
Victoria
Country 78323 0
Australia
Phone 78323 0
+61 3 9342 7000
Fax 78323 0
+61 3 9342 7802
Email 78323 0
andreas.pattichis@mh.org.au
Contact person for scientific queries
Name 78324 0
andrew (andreas) pattichis
Address 78324 0
the royal Melbourne hospital,
department of neurology,
300 Grattan street,
Parkville, 3050,
Victoria
Country 78324 0
Australia
Phone 78324 0
+61 3 9342 7000
Fax 78324 0
+61 3 9342 7802
Email 78324 0
andreas.pattichis@mh.org.au

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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