Respiratory FailureNCT07005596
Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
A study testing Passy-Muir Speaking Valve and Standard Non-Verbal Communication Methods in people with Respiratory Failure and Communication Disorders, run by Far Eastern Memorial Hospital.
Trial summary
This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Communication Disorders, Depression
- What is being tested?
- Passy-Muir Speaking Valve and Standard Non-Verbal Communication Methods
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old
- Consciousness: Glasgow Coma Scale (GCS) score 13-15 (can voluntarily open eyes or respond when called, able to follow instructions to move)
- Tracheostomy: Performed ≥24 hours, with no bleeding, pain, subcutaneous emphysema, pneumothorax, or infection
- Ventilator Weaning: Trained according to the hospital's Respiratory Care Center standards, able to undergo spontaneous breathing training during the day
- Ventilator Settings: FiO2 ≤40%
- Vital Signs: Stable:
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- Heart rate 60-100 beats/min
- Respiratory rate 12-20 breaths/min
- Systolic blood pressure <150 mmHg, diastolic blood pressure <90 mmHg
- Blood oxygen saturation 95-100%, no dyspnea complaints
- Richmond Agitation-Sedation Scale (RASS) between -1 and +1
- Language: Able to communicate in Mandarin, Taiwanese, or Hakka
- Consent: Willing to participate in the study
Who cannot join
- Recent surgery, anesthesia, or sedative use affecting consciousness
- Severe unstable vital signs or inability to breathe normally
- Upper airway obstruction or vocal cord paralysis
- High dependence on ventilators or high-concentration oxygen therapy
- History of depression or currently taking antidepressant medication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Impact of Early Tracheostomy Speaking Valve Intervention on Communication, Depression, and Quality of Life in Long-term Ventilator-dependent Patients During the Weaning Phase
This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase. Participants will be randomly assigned to either an experimental group using the Passy-Muir speaking valve or a control group employing standard non-verbal communication methods. Structured questionnaires will be used at multiple time points to assess changes in patient outcomes. The study aims to provide evidence supporting the use of speaking valves to enhance communication and emotional well-being in tracheostomy patients, potentially improving recovery and care strategies.
Read the detailed description
This randomized controlled trial investigates the effects of early intervention using the Passy-Muir speaking valve on communication, depression, and quality of life in tracheostomy patients undergoing ventilator weaning. The study will enroll 70 participants from the respiratory care center at Far Eastern Memorial Hospital, randomly assigned to either the experimental group (speaking valve intervention) or the control group (standard non-verbal communication methods). Data will be collected using validated assessment tools at baseline, week 1, week 2, and week 4. The primary outcomes include improvements in patient communication, reduction in depressive symptoms, and enhancement of overall quality of life. Statistical analysis will be conducted using SPSS 22.0, employing t-tests, chi-square tests, and generalized estimating equations (GEE). Ethical considerations include informed consent, patient confidentiality, and adherence to IRB-approved protocols. Findings from this study will contribute to evidence-based practices for tracheostomy patient care and guide clinical decision-making on communication strategies during ventilator weaning.
- Being tested
- Passy-Muir Speaking Valve, Standard Non-Verbal Communication Methods
- Keywords
- speaking valve, tracheostomy, communication
- Medical subject headings
- Respiratory Insufficiency, Communication Disorders, Depression, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passy-Muir Speaking ValveDevice
Also called Experimental Group
This intervention group receives early speaking valve intervention during ventilator weaning.
Standard Non-Verbal Communication MethodsBehavioural
Also called Control Group
This control group continues using conventional non-verbal communication methods such as gestures and lip-reading.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Speaking Valve Intervention) | Experimental | Participants in the experimental group will receive early intervention using the Passy-Muir speaking valve while undergoing ventilator weaning. This intervention aims to improve communication ability, reduce depression levels, and enhance quality of life. The intervention will be implemented at four different time points (Baseline, Week 1, Week 2, Week 4), with structured assessments for effectiveness Receives: Device: Passy-Muir Speaking Valve |
| Control Group (Standard Non-Verbal Communication) | Active comparator | Participants in the control group will continue using standard non-verbal communication methods, such as lip-reading and gestures, during ventilator weaning. This group serves as a comparison to assess the effectiveness of early speaking valve intervention in tracheostomy patients. Receives: Behavioral: Standard Non-Verbal Communication Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Ability (Measured using the Communication Difficulty Scale)
Communication ability will be assessed using the Communication Difficulty Scale (CDS), a validated instrument comprising 13 items designed to measure speech effectiveness in tracheostomy patients. Each item is rated on a 5-point Likert scale (0-4 per item, total score range: 0-52 points), where higher scores indicate greater communication difficulty. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3).
Statistical analysis will evaluate changes in communication ability over time using generalized estimating equations (GEE), accounting for intra-subject variability and adjusting for potential confounders such as age, underlying respiratory condition, and baseline cognitive function.
Measured: From enrollment to 4 weeks post-enrollment
Depression (Measured using the Patient Health Questionnaire-9, PHQ-9)
Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool widely used in clinical and research settings. The PHQ-9 consists of 9 items, each rated on a 4-point Likert scale (0-3 per item, total score range: 0-27 points), where higher scores indicate greater depressive symptoms. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3).
Statistical analysis will evaluate changes in depression scores over time using generalized estimating equations (GEE), adjusting for potential confounders such as age, baseline respiratory function, and pre-existing mental health conditions.
Measured: From enrollment to 4 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment design where participants are randomly allocated into either an intervention group receiving Passy-Muir speaking valves or a control group using conventional non-verbal communication methods. The effectiveness of the intervention is assessed through structured questionnaires measuring communication ability, depression levels, and quality of life over multiple time points. Data collectors remain blinded to group assignments to reduce bias in outcome assessments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005596
- Sponsor's protocol ID
- 114015-F
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Early Tracheostomy Speaking Valve Intervention on Communication, Depression, and Quality of Life in Long-term Ventilator-dependent Patients During the Weaning Phase
- ClinicalTrials.gov ID
- NCT07005596
- Acronym / sponsor ID
- 114015-F
- Keywords
- speaking valve, tracheostomy, communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase. Participants will be randomly assigned to either an experimental group using the Passy-Muir speaking valve or a control group employing standard non-verbal communication methods. Structured questionnaires will be used at multiple time points to assess changes in patient outcomes. The study aims to provide evidence supporting the use of speaking valves to enhance communication and emotional well-being in tracheostomy patients, potentially improving recovery and care strategies.
Detailed description
This randomized controlled trial investigates the effects of early intervention using the Passy-Muir speaking valve on communication, depression, and quality of life in tracheostomy patients undergoing ventilator weaning. The study will enroll 70 participants from the respiratory care center at Far Eastern Memorial Hospital, randomly assigned to either the experimental group (speaking valve intervention) or the control group (standard non-verbal communication methods). Data will be collected using validated assessment tools at baseline, week 1, week 2, and week 4. The primary outcomes include improvements in patient communication, reduction in depressive symptoms, and enhancement of overall quality of life. Statistical analysis will be conducted using SPSS 22.0, employing t-tests, chi-square tests, and generalized estimating equations (GEE). Ethical considerations include informed consent, patient confidentiality, and adherence to IRB-approved protocols. Findings from this study will contribute to evidence-based practices for tracheostomy patient care and guide clinical decision-making on communication strategies during ventilator weaning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment design where participants are randomly allocated into either an intervention group receiving Passy-Muir speaking valves or a control group using conventional non-verbal communication methods. The effectiveness of the intervention is assessed through structured questionnaires measuring communication ability, depression levels, and quality of life over multiple time points. Data collectors remain blinded to group assignments to reduce bias in outcome assessments.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Speaking Valve Intervention) | Experimental | Device: Passy-Muir Speaking ValveParticipants in the experimental group will receive early intervention using the Passy-Muir speaking valve while undergoing ventilator weaning. This intervention aims to improve communication ability, reduce depression levels, and enhance quality of life. The intervention will be implemented at four different time points (Baseline, Week 1, Week 2, Week 4), with structured assessments for effectiveness |
| Control Group (Standard Non-Verbal Communication) | Active comparator | Behavioral: Standard Non-Verbal Communication MethodsParticipants in the control group will continue using standard non-verbal communication methods, such as lip-reading and gestures, during ventilator weaning. This group serves as a comparison to assess the effectiveness of early speaking valve intervention in tracheostomy patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: ≥18 years old
- Consciousness: Glasgow Coma Scale (GCS) score 13-15 (can voluntarily open eyes or respond when called, able to follow instructions to move)
- Tracheostomy: Performed ≥24 hours, with no bleeding, pain, subcutaneous emphysema, pneumothorax, or infection
- Ventilator Weaning: Trained according to the hospital's Respiratory Care Center standards, able to undergo spontaneous breathing training during the day
- Ventilator Settings: FiO2 ≤40%
Key exclusion criteria (5 listed)
- Recent surgery, anesthesia, or sedative use affecting consciousness
- Severe unstable vital signs or inability to breathe normally
- Upper airway obstruction or vocal cord paralysis
- High dependence on ventilators or high-concentration oxygen therapy
- History of depression or currently taking antidepressant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passy-Muir Speaking ValveAlso: Experimental GroupThis intervention group receives early speaking valve intervention during ventilator weaning. | Device | Experimental Group (Speaking Valve Intervention) |
| Standard Non-Verbal Communication MethodsAlso: Control GroupThis control group continues using conventional non-verbal communication methods such as gestures and lip-reading. | Behavioural | Control Group (Standard Non-Verbal Communication) |
Primary outcome
Communication Ability (Measured using the Communication Difficulty Scale)
Time frame: From enrollment to 4 weeks post-enrollment
Communication ability will be assessed using the Communication Difficulty Scale (CDS), a validated instrument comprising 13 items designed to measure speech effectiveness in tracheostomy patients. Each item is rated on a 5-point Likert scale (0-4 per item, total score range: 0-52 points), where higher scores indicate greater communication difficulty. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3). Statistical analysis will evaluate changes in communication ability over time using generalized estimating equations (GEE), accounting for intra-subject variability and adjusting for potential confounders such as age, underlying respiratory condition, and baseline cognitive function.
Depression (Measured using the Patient Health Questionnaire-9, PHQ-9)
Time frame: From enrollment to 4 weeks post-enrollment
Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool widely used in clinical and research settings. The PHQ-9 consists of 9 items, each rated on a 4-point Likert scale (0-3 per item, total score range: 0-27 points), where higher scores indicate greater depressive symptoms. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3). Statistical analysis will evaluate changes in depression scores over time using generalized estimating equations (GEE), adjusting for potential confounders such as age, baseline respiratory function, and pre-existing mental health conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Passy-Muir Speaking Valve and Standard Non-Verbal Communication Methods in people with Respiratory Failure and Communication Disorders, run by Far Eastern Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHIA CHI HSU (+8860960606032, jiaqi92058@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication Ability (Measured using the Communication Difficulty Scale) (time frame: From enrollment to 4 weeks post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.