Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Laryngectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04943731
• Other study ID #: HREC/2021/QMS/74792
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: May 2023
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngectomy

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Prince of Wales Hospital, NSW	Sydney	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (4)

Lead Sponsor	Collaborator
Atos Medical AB	Prince of Wales Hospital, Sydney, Princess Alexandra Hospital, Brisbane, Australia, Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

References & 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 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Questionnaire for Skin Integrity	Patient reported	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary	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)
Secondary	Questionnaire to assess Shortness of Breath	from Ackerstaff et al., 1993	Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)