Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Changes in Pulmonary Outcomes as a Result of Implementing a Day and Night Regimen With Heat and Moisture Exchangers (HMEs) and Their Attachments

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.

Study Overview

• Status: Completed
• Conditions: Laryngectomy
• Intervention / Treatment: Device: Provox Life

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2031
      • Prince of Wales Hospital, NSW
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: Provox Life; Phase 1: Like for like transition, Phase 2: Provox Life day/night regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in COUS score of CASA-Q	Cough Symptoms (COUS) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Change COUI scores of CASA-Q	Cough Impact (COUI) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SPUS score of CASA-Q	Sputum Symptoms (SPUS) domains of the CASA-Q. Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Change in SPUI score of CASA-Q	Sputum Impact (SPUI) domains of the CASA-Q. Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Change in COUS scores of CASA-Q	Cough Symptoms (COUS) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Change in COUI scores of CASA-Q	CCough Impact (COUI) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Number of forced mucus expectorations per 24 hours	Patient reported, recorded by tally sheeting	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Number of involuntary coughs per 24 hours	Patient reported, recorded by tally sheeting	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Quality of Life by EQ-5D-5L	patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicatinghigher health utility	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire for Skin Integrity	Patient reported	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Jenkins sleep evaluation questionnaire	Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire to assess Shortness of Breath	from Ackerstaff et al., 1993	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire to adjustment to Day/Night regimen	Study specific questionnaire to describe patients adjustment to Day/Night regimen	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Consumption of medical devices (Number of devices used)	Number of devices used, by use of patient diary recoding number of devices used	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Study-specific questionnaire to assess number of complications and medical treatments	Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Study-specific questionnaire to assess patients satisfaction	patient satisfaction with devices and regimen	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

Collaborators and Investigators

• Sponsor: Atos Medical AB
• Collaborators: Royal Brisbane and Women's Hospital; Princess Alexandra Hospital, Brisbane, Australia; Prince of Wales Hospital, Sydney
• Investigators: Principal Investigator: Elizabeth C Ward, PhD, Centre for functioning and Health Research, Metro South Hospital and Health Service

Publications and helpful links

General Publications

• Ward EC, Hancock K, Boxall J, Burns CL, Spurgin AL, Lehn B, Hoey J, Robinson R, Coleman A. Post-laryngectomy pulmonary and related symptom changes following adoption of an optimal day-and-night heat and moisture exchanger (HME) regimen. Head Neck. 2023 Apr;45(4):939-951. doi: 10.1002/hed.27323. Epub 2023 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): April 4, 2022
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; Heat and Moisture Exchangers
• Other Study ID Numbers: HREC/2021/QMS/74792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No