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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04943731




Registration number
NCT04943731
Ethics application status
Date submitted
7/06/2021
Date registered
29/06/2021
Date last updated
15/05/2023

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
N/A
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
Other
Name [2] 0 0
Royal Brisbane and Women's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
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
Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing
a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range
of HMEs". The main purpose of this study is to find out if participants experience any
differences in the amount of coughing and mucus problems when using the new range of Provox
Life™ HMEs (and attachment devices) following an optimal Day/Night regimen. The study is
sponsored by Atos Medical.

Study Design: Participants will use the new Provox Life™ HME range and their attachments
during two (2) observation phases (Phase 1, Phase 2). In Phase 1 (6 week study phase),
participants will use the new Provox Life™ HMEs in a similar way as they currently use their
existing HME devices. In the Phase 2 (6 week study phase), they will use the Provox Life™ HME
devices following an optimal Day/Night regimen - with the aim to achieve the best possible
humidification at all times. Prior to each study phase, participants will meet with their
speech pathologist to learn about the new devices and how to use them. Once comfortable using
them they will commence each observation phase.

Data Collection: Experiences using their existing HMEs (prior to study) and then using the
new HMEs in Phase 1 and Phase 2 will be collected via a series of questionnaires. These will
be completed 5 times in total - at baseline before Phase 1 starts, and then at both week 2
and week 6 of Phase 1 and 2. Questionnaires relate to their use of the HMEs, coughing and
mucus problems, skin integrity, overall experiences of using the new devices and any impacts
on sleep and quality of life. Participants will complete some of the questionnaires at home
(approx. 30mins) and the others during an interview session with one of the study team
(approx. 30mins). The interview session can be conducted via telephone, videoconferencing or
in person - depending on the patients preferences and any COVID restrictions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04943731
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04943731