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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04943731




Registration number
NCT04943731
Ethics application status
Date submitted
7/06/2021
Date registered
29/06/2021

Titles & IDs
Public title
Day/Night Regimen With Provox Life Heat and Moisture Exchangers
Scientific title
Changes in Pulmonary Outcomes as a Result of Implementing a Day and Night Regimen With Heat and Moisture Exchangers (HMEs) and Their Attachments
Secondary ID [1] 0 0
HREC/2021/QMS/74792
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laryngectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Provox Life

Other: Provox Life™ - Phase 1: Provox Life™. Like-for-like transition from Provox (or other brand) to Provox Life™ under guidance from Speech Pathologist who will assess when the participant is ready to commence the 6 week study observation period.

Phase 2: Provox Life™ with Day/Night regimen. Establishment of optimal day/night routine under guidance of Speech Pathologist who will assess when the participant is ready to commence the 6 week observation period.


Treatment: Devices: Provox Life
Phase 1: Like for like transition, Phase 2: Provox Life day/night regimen
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in COUS score of CASA-Q
Timepoint [1] 0 0
Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Primary outcome [2] 0 0
Change COUI scores of CASA-Q
Timepoint [2] 0 0
Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Secondary outcome [1] 0 0
Change in SPUS score of CASA-Q
Timepoint [1] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [2] 0 0
Change in SPUI score of CASA-Q
Timepoint [2] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [3] 0 0
Change in COUS scores of CASA-Q
Timepoint [3] 0 0
Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Secondary outcome [4] 0 0
Change in COUI scores of CASA-Q
Timepoint [4] 0 0
Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Secondary outcome [5] 0 0
Number of forced mucus expectorations per 24 hours
Timepoint [5] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [6] 0 0
Number of involuntary coughs per 24 hours
Timepoint [6] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [7] 0 0
Quality of Life by EQ-5D-5L
Timepoint [7] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [8] 0 0
Questionnaire for Skin Integrity
Timepoint [8] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [9] 0 0
Jenkins sleep evaluation questionnaire
Timepoint [9] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [10] 0 0
Questionnaire to assess Shortness of Breath
Timepoint [10] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [11] 0 0
Questionnaire to adjustment to Day/Night regimen
Timepoint [11] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [12] 0 0
Consumption of medical devices (Number of devices used)
Timepoint [12] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [13] 0 0
Study-specific questionnaire to assess number of complications and medical treatments
Timepoint [13] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary outcome [14] 0 0
Study-specific questionnaire to assess patients satisfaction
Timepoint [14] 0 0
Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

Eligibility
Key inclusion criteria
* Total laryngectomy, irrespective of pharynx reconstruction method
* 18 years or older
* HME user
* Longer than 3 months after total laryngectomy
* Longer than 6 weeks after postoperative radiotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current day/night routine with Provox Luna
* Daily use of Provox Micron HMEF
* Medical problems prohibiting the use of HME
* Active recurrent or metastatic disease (medical deterioration)
* Recent pulmonary infections/unstable pulmonary condition
* Reduced mobility of arms and/or hands, unable to insert or remove an HME
* Unable to understand the Participant Information and/or unable to give Informed Consent
* Insufficient cognitive ability to manage HME or adhesive use

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/04/2022
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Prince of Wales Hospital, NSW - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atos Medical AB
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Royal Brisbane and Women's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Prince of Wales Hospital, Sydney
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Elizabeth C Ward, PhD
Address 0 0
Centre for functioning and Health Research, Metro South Hospital and Health Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

TypeCitations or Other Details
Journal Ward EC, Hancock K, Boxall J, Burns CL, Spurgin AL... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT04943731