Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001192572
Ethics application status
Approved
Date submitted
6/09/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of cyclical deep pressure applied by the FLOWpresso device on sleep in adults with disturbed sleep
Scientific title
Effects of cyclical deep pressure applied by the FLOWpresso device on sleep in adults with disturbed sleep
Secondary ID [1] 312918 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 335082 0
Condition category
Condition code
Public Health 331585 331585 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three, 40-minute intervention sessions over a 3-week period, with one session per week of compression and infra-red light exposure using a specially designed suit.
Specifically, the participant lies supine on a plinth and the components on the device as secured to the body using Velcro wraps in a manner similar to a blood pressure monitor. The compression chambers are then sequentially inflated to deliver cycles of pneumatic pressure. At the same time as the compression occurs, infrared light in the 300 to 1000 nm range is also applied. A researcher will deliver the intervention in a quiet and private clinical setting, while monitoring the participant at all times through direct observation.
Intervention code [1] 329451 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339324 0
Sleep
Timepoint [1] 339324 0
Baseline and 1 week following the completion of the treatment.
Secondary outcome [1] 439453 0
Anxiety
Timepoint [1] 439453 0
Baseline and 1 week following the completion of the treatment.

Eligibility
Key inclusion criteria
18 years or older; actively working in a first responder in a government department; regular symptoms of disturbed sleep, and/or distress, and/or anxiety; and never been treated with the intervention device previously
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or breast feeding; any diagnoses cardiopulmonary disorder or symptoms of congestive heart failure; requiring a pacemaker; scoliosis; history of blood clots or deep vein thrombosis; or unstable psychiatric illness

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/01/2021
Date of last participant enrolment
Anticipated
Actual
22/02/2021
Date of last data collection
Anticipated
Actual
29/03/2021
Sample size
Target
300
Accrual to date
Final
173
Recruitment outside Australia
Country [1] 26550 0
New Zealand
State/province [1] 26550 0

Funding & Sponsors
Funding source category [1] 317350 0
Charities/Societies/Foundations
Name [1] 317350 0
Callaghan Innovation
Country [1] 317350 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 319638 0
None
Name [1] 319638 0
Address [1] 319638 0
Country [1] 319638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316081 0
University of Waikato Human Research Ethics Committee (Health)
Ethics committee address [1] 316081 0
Ethics committee country [1] 316081 0
New Zealand
Date submitted for ethics approval [1] 316081 0
27/11/2020
Approval date [1] 316081 0
21/01/2021
Ethics approval number [1] 316081 0

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

Contacts
Principal investigator
Name 136718 0
Dr Martyn Beaven
Address 136718 0
University of Waikato Adams Centre for High Performance, 52 Miro St, 3116, Tauranga
Country 136718 0
New Zealand
Phone 136718 0
+64 225030577
Fax 136718 0
Email 136718 0
[email protected]
Contact person for public queries
Name 136719 0
Martyn Beaven
Address 136719 0
University of Waikato Adams Centre for High Performance, 52 Miro St, 3116, Tauranga
Country 136719 0
New Zealand
Phone 136719 0
+64 225030577
Fax 136719 0
Email 136719 0
[email protected]
Contact person for scientific queries
Name 136720 0
Martyn Beaven
Address 136720 0
University of Waikato Adams Centre for High Performance, 52 Miro St, 3116, Tauranga
Country 136720 0
New Zealand
Phone 136720 0
+64 225030577
Fax 136720 0
Email 136720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.