Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Study Overview
=================
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.

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

Conditions
-----------------
Laryngectomy

Intervention / Treatment
-----------------
* Device: Provox Life


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional Model Description: Multi-center, prospective, two-phase clinical study. The end of Phase 1 serves as the baseline for Phase 2.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Provox Life™<br>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<br>* Phase 1: Like for like transition, Phase 2: Provox Life day/night regimen<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary rehabilitation, Heat and Moisture Exchangers