Prolonged Mechanical VentilationNCT07200037
Effects of IMT on Weaning and Diaphragmatic Function in PMV Patients
A study testing inspiratory muscle training in people with Prolonged Mechanical Ventilation, run by Capital Medical University.
Trial summary
Prolonged mechanical ventilation (PMV) and weaning failure can lead to extended hospital stays, as well as increased morbidity and mortality during hospitalization. Therefore, PMV not only increases the economic burden on patients and their families, but also adds to the societal economic burden and consumes critical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Mechanical Ventilation
- What is being tested?
- inspiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Sep 2026
- 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
- Patients who received therapy in the HDU of the Respiratory Rehabilitation Center of Beijing Rehabilitation Hospital Affiliated to Capital Medical University and met the PMV criteria clearly recommended by the NAMDRC consensus in 2005, which is "mechanical ventilation for at least 6 hours a day for 21 consecutive days".
- The patients' conditions were relatively stable, they were conscious, had no intellectual disability, no mental illness, no cognitive impairment, and gave informed consent.
- They had spontaneous breathing and could tolerate short periods of being off the ventilator to complete the training.
- The ventilator parameters met the following requirements: PEEP ≤ 10 cmH2O, FiO2 < 0.60, RR < 25.
Who cannot join
- 1) brain injuries, pulmonary contusions and lacerations, rib fractures, unhealed wounds in the chest and abdomen, etc. The condition is severe, and inspiratory muscle training and diaphragm ultrasound assessment cannot be performed. 2) No spontaneous breathing, completely dependent on mechanical ventilation; 3) Pre-existing pulmonary infection or severe heart, lung or kidney diseases before clinical trials, with unstable hemodynamics; 4) Poor cognitive function, poor compliance, and non-cooperation with treatment.-
About this study
Official title: Effects of Inspiratory Muscle Training on Weaning and Diaphragmatic Function in Prolonged Mechanical Ventilation Patients: A Multicenter Randomized Controlled Trial
Prolonged mechanical ventilation (PMV) and weaning failure can lead to extended hospital stays, as well as increased morbidity and mortality during hospitalization. Therefore, PMV not only increases the economic burden on patients and their families, but also adds to the societal economic burden and consumes critical care medical resources. Inspiratory muscle training (IMT) is widely used by physical therapists in critically ill patients to improve respiratory function and enhance quality of life. IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function in turn promotes better respiratory function, which is clinically significant for accelerating weaning. However, most studies on the effects of IMT on weaning success rates and the duration of mechanical ventilation have limitations such as small sample sizes, homogeneous patient populations, and short intervention periods. As a result, there is still no unified, high-quality evidence-based consensus. The purpose of this study is to further clarify the role of IMT in improving diaphragmatic function and increasing weaning success rates in patients with prolonged weaning, through clinical treatment and the collection and analysis of relevant data.
Read the detailed description
In recent years, inspiratory muscle training (IMT) has been widely used by physical therapists in critically ill patients to improve their respiratory function and enhance their quality of life. IMT is safe and feasible for a specific group of patients dependent on ventilators . This training not only improves inspiratory muscle strength but also increases the possibility of patients successfully being weaned off ventilators . In addition, patients who successfully weaned off the ventilator and continued with IMT also helped improve their quality of life. The current health status measured by EQ-5D VAS indicated that the symptoms of the inspiratory muscle training group improved by 12% compared with the control group. Therefore, IMT may serve as one of the training methods for physical therapists to improve the diaphragmatic function of patients with delayed weaning and increase the success rate of weaning.
In terms of the impact on the success rate of weaning from aircraft, the results of multiple randomized controlled trials and meta-analyses indicate that IMT plays a positive role in enhancing the success rate of weaning from aircraft. The results of a randomized clinical trial showed that the weaning time of the IMT group was significantly shorter than that of the control group, specifically 12.6 days compared with 18.1 days, with a P value of 0.04. This indicates that IMT can effectively shorten the duration of mechanical ventilation, thereby increasing the possibility of successful weaning. Marine pointed out in a recent article that both high-intensity IMT and low-intensity IMT can improve the MIP of patients with mechanical ventilation, increase the success rate of weaning from the ventilator and reduce the duration of mechanical ventilation, but there is no significant difference between the two groups. In addition, in this study, the forced vital capacity (FVC) of the patients increased more in the high-intensity IMT group. The absence of significant differences between the two groups in this study might be due to the fact that the study only lasted for 4 weeks, which was a relatively short intervention period. Furthermore, another systematic review revealed that although IMT could improve maximal inspiratory pressure and the Rapid Shallow Breathing Index (RSBI), no significant difference was found in the success rate of weaning from the ventilator, indicating that although IMT can enhance the strength of respiratory muscles, But it does not necessarily directly lead to a higher success rate of flight withdrawal. The effect of IMT on patients with difficult weaning due to different causes also varies. For instance, IMT studies on patients with chronic obstructive pulmonary disease (COPD) have shown that IMT not only enhances respiratory muscle strength but also improves lung function indicators, thereby improving the weaning effect. However, other studies have pointed out that the effect of IMT in patients with neuromuscular diseases is relatively limited, possibly because these patients themselves have more complex respiratory muscle weakness problems. Regarding the research on the success rate of weaning from the ventilator and the duration of mechanical ventilation by IMT, most studies have problems such as small sample size, single patient population and short intervention time. Therefore, there is no unified and high-quality evidence-based basis yet.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
- Conditions
- Prolonged Mechanical Ventilation
- Being tested
- inspiratory muscle training
- Keywords
- Inspiratory muscle training, Prolonged mechanical ventilation, weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingBehavioural
This intervention will include a long term program of 8 weeks IMT in PMV patients who these patients who have required at least 6h of mechanical ventilation for 21 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| IMT group | Experimental | In this group, external load, initially 50%MIP , was daily adjusted to the highest tolerable load. The training is carried out 5 days a week for 8 weeks. The patient's MIP is measured every two weeks to adjust the training parameters in a timely manner to suit the patient's condition. Receives: Behavioral: inspiratory muscle training |
| sham-IMT group | Sham comparator | In this group, external load and maximal 10% MIP remained unadjusted. The training is carried out 5 days a week. The patient's MIP is measured every two weeks to adjust the training parameters in a timely manner to suit the patient's condition. Receives: Behavioral: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning success rate
Measured: From enrollment to the end of treatment at 12 week
Secondary outcomes (4)
Diaphragmatic function
DE in centimeter、thickness in millimeter、DTF in proportion
Measured: from enrollment to the end of the treatment at 12 weeks
maximal inspiratory pressure
Measured: from enrollment to the end of the treatment at 8 weeks
EQ-5D-5L
Measured: From enrollment to the end of the intervention at 12 week
FVC(forced vital capacity)
FVC in liters
Measured: from enrollment to the end of the ventilation at 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo Chen, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200037
- Sponsor's protocol ID
- 20250817001
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Weaning and Diaphragmatic Function in Prolonged Mechanical Ventilation Patients: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07200037
- Acronym / sponsor ID
- 20250817001
- Conditions
- Prolonged Mechanical Ventilation
- Keywords
- Inspiratory muscle training, Prolonged mechanical ventilation, weaning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 Sep 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.
Prolonged mechanical ventilation (PMV) and weaning failure can lead to extended hospital stays, as well as increased morbidity and mortality during hospitalization. Therefore, PMV not only increases the economic burden on patients and their families, but also adds to the societal economic burden and consumes critical care medical resources. Inspiratory muscle training (IMT) is widely used by physical therapists in critically ill patients to improve respiratory function and enhance quality of life. IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function in turn promotes better respiratory function, which is clinically significant for accelerating weaning. However, most studies on the effects of IMT on weaning success rates and the duration of mechanical ventilation have limitations such as small sample sizes, homogeneous patient populations, and short intervention periods. As a result, there is still no unified, high-quality evidence-based consensus. The purpose of this study is to further clarify the role of IMT in improving diaphragmatic function and increasing weaning success rates in patients with prolonged weaning, through clinical treatment and the collection and analysis of relevant data.
Detailed description
In recent years, inspiratory muscle training (IMT) has been widely used by physical therapists in critically ill patients to improve their respiratory function and enhance their quality of life. IMT is safe and feasible for a specific group of patients dependent on ventilators . This training not only improves inspiratory muscle strength but also increases the possibility of patients successfully being weaned off ventilators . In addition, patients who successfully weaned off the ventilator and continued with IMT also helped improve their quality of life. The current health status measured by EQ-5D VAS indicated that the symptoms of the inspiratory muscle training group improved by 12% compared with the control group. Therefore, IMT may serve as one of the training methods for physical therapists to improve the diaphragmatic function of patients with delayed weaning and increase the success rate of weaning.
In terms of the impact on the success rate of weaning from aircraft, the results of multiple randomized controlled trials and meta-analyses indicate that IMT plays a positive role in enhancing the success rate of weaning from aircraft. The results of a randomized clinical trial showed that the weaning time of the IMT group was significantly shorter than that of the control group, specifically 12.6 days compared with 18.1 days, with a P value of 0.04. This indicates that IMT can effectively shorten the duration of mechanical ventilation, thereby increasing the possibility of successful weaning. Marine pointed out in a recent article that both high-intensity IMT and low-intensity IMT can improve the MIP of patients with mechanical ventilation, increase the success rate of weaning from the ventilator and reduce the duration of mechanical ventilation, but there is no significant difference between the two groups. In addition, in this study, the forced vital capacity (FVC) of the patients increased more in the high-intensity IMT group. The absence of significant differences between the two groups in this study might be due to the fact that the study only lasted for 4 weeks, which was a relatively short intervention period. Furthermore, another systematic review revealed that although IMT could improve maximal inspiratory pressure and the Rapid Shallow Breathing Index (RSBI), no significant difference was found in the success rate of weaning from the ventilator, indicating that although IMT can enhance the strength of respiratory muscles, But it does not necessarily directly lead to a higher success rate of flight withdrawal. The effect of IMT on patients with difficult weaning due to different causes also varies. For instance, IMT studies on patients with chronic obstructive pulmonary disease (COPD) have shown that IMT not only enhances respiratory muscle strength but also improves lung function indicators, thereby improving the weaning effect. However, other studies have pointed out that the effect of IMT in patients with neuromuscular diseases is relatively limited, possibly because these patients themselves have more complex respiratory muscle weakness problems. Regarding the research on the success rate of weaning from the ventilator and the duration of mechanical ventilation by IMT, most studies have problems such as small sample size, single patient population and short intervention time. Therefore, there is no unified and high-quality evidence-based basis yet.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
In conclusion, IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function will promote the improvement of respiratory function in patients, which also has certain clinical significance for accelerating weaning from the ventilator. Under the condition that our department is equipped with multiple physical therapists with experience in implementing IMT, the assessment and intervention of patients with delayed weaning in the intensive care unit were completed through the joint efforts of medical, nursing and technical staff. The success rate of weaning was the main result, and the diaphragm mobility, diaphragm thickness and diaphragm thickening fraction in the diaphragm ultrasound results were the secondary results to conduct this study. The aim is to further clarify the impact of inspiratory muscle strength training on the successful weaning of patients with delayed weaning and the improvement of diaphragmatic function through clinical treatment and data collection and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Behavioral: inspiratory muscle trainingIn this group, external load, initially 50%MIP , was daily adjusted to the highest tolerable load. The training is carried out 5 days a week for 8 weeks. The patient's MIP is measured every two weeks to adjust the training parameters in a timely manner to suit the patient's condition. |
| sham-IMT group | Sham comparator | Behavioral: inspiratory muscle trainingIn this group, external load and maximal 10% MIP remained unadjusted. The training is carried out 5 days a week. The patient's MIP is measured every two weeks to adjust the training parameters in a timely manner to suit the patient's condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who received therapy in the HDU of the Respiratory Rehabilitation Center of Beijing Rehabilitation Hospital Affiliated to Capital Medical University and met the PMV criteria clearly recommended by the NAMDRC consensus in 2005, which is "mechanical ventilation for at least 6 hours a day for 21 consecutive days".
Key exclusion criteria (1 listed)
- 1) brain injuries, pulmonary contusions and lacerations, rib fractures, unhealed wounds in the chest and abdomen, etc. The condition is severe, and inspiratory muscle training and diaphragm ultrasound assessment cannot be performed. 2) No spontaneous breathing, completely dependent on mechanical ventilation; 3) Pre-existing pulmonary infection or severe heart, lung or kidney diseases before clinical trials, with unstable hemodynamics; 4) Poor cognitive function, poor compliance, and non-cooperation with treatment.-
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 |
|---|---|---|
| inspiratory muscle trainingThis intervention will include a long term program of 8 weeks IMT in PMV patients who these patients who have required at least 6h of mechanical ventilation for 21 consecutive days. | Behavioural | IMT group, sham-IMT group |
Primary outcome
weaning success rate
Time frame: From enrollment to the end of treatment at 12 week
4 secondary outcomes
Diaphragmatic function
Time frame: from enrollment to the end of the treatment at 12 weeks
maximal inspiratory pressure
Time frame: from enrollment to the end of the treatment at 8 weeks
EQ-5D-5L
Time frame: From enrollment to the end of the intervention at 12 week
FVC(forced vital capacity)
Time frame: from enrollment to the end of the ventilation at 12 week
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 30 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training in people with Prolonged Mechanical Ventilation, run by Capital Medical University.
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 4 inclusion and 1 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 30 Sep 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning success rate (time frame: From enrollment to the end of treatment at 12 week). 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 30 Sep 2025.