Day/Night Regimen With Provox Life Heat and Moisture Exchangers

NCT04943731 | Completed

• 1 other identifier: HREC/2021/QMS/74792
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Laryngectomy

Keywords

Pulmonary rehabilitation; Heat and Moisture Exchangers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Change in SPUS score of CASA-Q

  Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

• Change in SPUI score of CASA-Q

  Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

• Change in COUS scores of CASA-Q

  Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)

• Change in COUI scores of CASA-Q

  Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)

• Number of forced mucus expectorations per 24 hours

  Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

Study Arms (1)

Provox Life™

OTHER

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

Interventions

Provox Life DEVICE

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

Provox Life™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total laryngectomy, irrespective of pharynx reconstruction method
• years or older
• HME user
• Longer than 3 months after total laryngectomy
• Longer than 6 weeks after postoperative radiotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Atos Medical AB: lead
• Princess Alexandra Hospital, Brisbane, Australia: collaborator
• Royal Brisbane and Women's Hospital: collaborator
• Prince of Wales Hospital, Sydney: collaborator

Study Sites (3)

Prince of Wales Hospital, NSW

Sydney, New South Wales, 2031, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Related Publications (1)

• 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.

  PMID: 36808179 RESULT

Study Officials

• Elizabeth C Ward, PhD

  Centre for functioning and Health Research, Metro South Hospital and Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, prospective, two-phase clinical study. The end of Phase 1 serves as the baseline for Phase 2.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 29, 2021
• Study Start: July 26, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)