Disorder of ConsciousnessNCT05308186
Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness
A study testing Auditory stimulation and Auditory and tactile stimulations in people with Disorder of Consciousness, run by Tel Aviv University at 1 site in Israel.
Trial summary
The aim of the presented study is to examine the effectiveness of sensory stimulation in reducing pain and stress of patients diagnosed with Disorder of consciousness. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Auditory stimulation and Auditory and tactile stimulations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Apr 2022to 18 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable vital and essential signs taken from a nurse report
- A score between 1-4 in Coma Near Coma scale.
Who cannot join
- Spinal cord injury
- Past neurological disorders
- Past psychiatric disorders
- Pressure ulcers
- Prolonged fever
- Cellulite in one limb or more
- Urine retention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness, Hospitalized in a Prolonged Respiratory Department- A Pilot Study
The aim of the presented study is to examine the effectiveness of sensory stimulation in reducing pain and stress of patients diagnosed with Disorder of consciousness.
Read the detailed description
Background: Disorder of consciousness (DOC) is a medical state in which the person's ability to be aware of himself and his surroundings is impaired due to an acquired brain injury. Neuroimaging during nociceptive stimulation in patients with DOC shows an activation in the network affiliated with the affective dimension of pain, providing evidence that patients can feel pain without behavioral signs. While patients not experiencing DOC receive medical care for reducing pain derived from daily medical procedures, patients with DOC receiving these same medical procedures do not receive such care for pain alleviation. Sensory stimulation has been found as an effective intervention for the stabilization and improvement of physiological signs, yet its' effectiveness in reducing pain in patients with DOC has not been studied.
Methods: Crossover experimental research will be conducted on one focus group without a control group, that includes recurring tests prior and after intervention. At the first stage of the research, the data will be collected twice a day, for fourteen days, once when the patient is in rest and once pre- and post-endotracheal suction. The second stage will include interventions based on two arms - auditory stimulation and a combination of auditory and tactile stimulations at the same time. Measures will be collected in days one, seven and fourteen in each arm. All measures will be applied pre- and post-endotracheal suction which will be conducted after the intervention period, as specified above, and during a patient rest period before and after intervention. Both interventions will be conducted for ten minutes each, twice daily, for fourteen days.
Population: After receiving consent to participate in the study from a guardian,15 adults aged 30-75, diagnosed with DOC, hospitalized in prolonged respiratory department will participate.
Tools: Physiological signs, behavioral pain scale, Modify Ashworth Scale, Brain Engagement Index.
Expected Results:
- Statistical significance will be found between measurements prior to interventions (control) and after interventions, both during rest (clinical pain) and during medical procedures, in the following measures:
- Physiological signs (blood pressure, pulse and respiratory indices) post intervention will be lower.
- Degree of spasticity post intervention will be lower.
- Pain levels post intervention will be lower.
- Statistical significance will be found in the levels of attention during interventions (sensory stimulations) in comparison to before the interventions (control), where the former will be higher in comparison to the latter.
- Statistical significance will be found in the efficiency of multi-sensory stimulations in comparison to a single sensory stimulation, where the former will show lower physiological signs, spasticity, and levels of pain during rest and medical procedures.
Findings may improve the quality of life in patients with respiratory distress, diagnosed with DOC, providing additional treatment options for pain management other than medications.
- Conditions
- Disorder of Consciousness
- Being tested
- Auditory stimulation, Auditory and tactile stimulations
- Keywords
- disorders of consciousness, pain, prolonged respiratory failure, sensory stimulation
- Medical subject headings
- Consciousness Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory stimulationBehavioural
The patient will be exposed to music that he used to enjoy (from the family's or guardian's report) through headphones. In case no report is given, nature (brook) sounds will be streamed.
Auditory and tactile stimulationsBehavioural
The patient will be exposed to music that he used to enjoy (from the family's or guardian's report, otherwise nature (brook) music will be streamed) through headphones combined with deep tissue massage will be given on the upper limbs.
| Study group | Role | What they receive |
|---|---|---|
| Auditory stimulation | Experimental | Exposing the patient to an audio-based stimulus. Receives: Behavioral: Auditory stimulation |
| Auditory and tactile stimulations | Experimental | Combination of tactual and audio-based stimuli. Receives: Behavioral: Auditory and tactile stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral pain scale (BPS) change
BPS evaluates three behavioral domains (facial expressions, movement of upper limbs, and compliance with ventilation) that are based on observation of the patient body's posture and his response to a nociceptive stimulation. Each subscale is scored from 1 (no response) to 4 (full response). Therefore, possible BPS scores range from 3 (no pain) to 12 (maximum pain).
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
Modify Ashworth scale (MAS) change
MAS is used to measure the increase of muscle tone which is manifested by an increased resistance of joints to passive movement. The MAS measures on the following 6 level ordinal scale: 0 = no increased resistance; 1 = slightly increased resistance (catch followed by relaxation or minimal resistance at the end of the range of motion); 1+ = slightly increased resistance (catch followed by minimal resistance throughout less than half of the range of motion); 2 = clear resistance throughout most of the range of motion; 3 = strong resistance; passive movement is difficult; 4 = rigid flexion or extension.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
EEG brainwave change
EEG will be sampled using the Mind-Wave dry electrode system, with one frontal electrode and one reference electrode on the earlobe, at a sampling rate of 512Hz. Positioning of the electrode conforms with the goal of monitoring prefrontal activity, which may correlate with attention regardless of the site of lesion. The sampled data is transferred through a wireless connection to the computer, where the Brain Engagement Index (BEI) is processed in real-time every 10 seconds and presented by the BEI monitor.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
Respiratory Rate (RR) change
The set ventilatory rate is the minimum number of breaths delivered to the patient per minute. The actual rate may be higher than the set rate if the patient is initiating spontaneous breaths. Rate is also a determinant of ventilation and is adjusted in response to the patient's CO2 (carbon dioxide) levels. RR will be collected from the patient's respiratory machine.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Tidal Volume (TV) change
Tidal volume (TV) is the volume of gas delivered to the patient with each breath. Tidal volume may also be expressed as TV. TV is only set for volume-controlled modes of ventilation and is usually 8-12cc/kg of body weight. TV will be collected from the patient's respiratory machine.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Peak Inspiratory Pressure (PIP) change
Inspiratory pressure reflects global alveolar pressure and is monitored continuously. The maximum allowable PIP is set on the ventilator. If the PIP exceeds the set value, an alarm will sound, and gas delivery will halt until the next breath is triggered. The normal peak inspiratory pressure on a mechanically ventilated patient with normal lungs is approximately 20cm H2O (water). The maximum allowable peak pressure varies from patient to patient. The pulmonologists determine the safest pressure for each patient. PIP values should be trended in volume-controlled modes to detect changes in pulmonary compliance. PIP will be collected from the patient's respiratory machine.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Systolic Blood Pressure (SBP) change
SBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Cross-sectional values for systolic blood pressure: norm 120-129, normal-high 130-139, and hypertension ≥140. SBP will be collected using a monitoring equipment located in the departments.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Diastolic Blood Pressure (DBP) change
DBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Optimal diastolic blood pressure values <80, with cross-sectional points to norm 80-84, normal-high 85-89, and hypertension ≥90. DBP will be collected using a monitoring equipment located in the departments.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Heart Rate (HR) change
HR will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. The average pulse value is 60-80 beats per minute. HR will be collected using a monitoring equipment located in the departments.
Measured: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start10 Apr 2022
- Primary completion18 Sep 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Samson Assuta Ashdod Hospital, Bet Hadar- Medical rehabilitation and nursing center
- Responsible party
- Principal investigator, Tami Bar-Shalita, Tel Aviv University
- Investigators
- Shely Farag Harpak, B.O.T, Study chair, Tel Aviv UniversityYoseph Mishal, Dr., Principal investigator, Bet Hadar- Medical rehabilitation and nursing center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308186
- Sponsor's protocol ID
- 0151-21-AAA
- Status last verified
- Nov 2023
- First submitted
- 24 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon personal request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness, Hospitalized in a Prolonged Respiratory Department- A Pilot Study
- ClinicalTrials.gov ID
- NCT05308186
- Acronym / sponsor ID
- 0151-21-AAA
- Conditions
- Disorder of Consciousness
- Keywords
- disorders of consciousness, pain, prolonged respiratory failure, sensory stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Samson Assuta Ashdod Hospital, Bet Hadar- Medical rehabilitation and nursing center
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 18 Sep 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 1 Apr 2022 (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.
The aim of the presented study is to examine the effectiveness of sensory stimulation in reducing pain and stress of patients diagnosed with Disorder of consciousness.
Detailed description
Background: Disorder of consciousness (DOC) is a medical state in which the person's ability to be aware of himself and his surroundings is impaired due to an acquired brain injury. Neuroimaging during nociceptive stimulation in patients with DOC shows an activation in the network affiliated with the affective dimension of pain, providing evidence that patients can feel pain without behavioral signs. While patients not experiencing DOC receive medical care for reducing pain derived from daily medical procedures, patients with DOC receiving these same medical procedures do not receive such care for pain alleviation. Sensory stimulation has been found as an effective intervention for the stabilization and improvement of physiological signs, yet its' effectiveness in reducing pain in patients with DOC has not been studied.
Methods: Crossover experimental research will be conducted on one focus group without a control group, that includes recurring tests prior and after intervention. At the first stage of the research, the data will be collected twice a day, for fourteen days, once when the patient is in rest and once pre- and post-endotracheal suction. The second stage will include interventions based on two arms - auditory stimulation and a combination of auditory and tactile stimulations at the same time. Measures will be collected in days one, seven and fourteen in each arm. All measures will be applied pre- and post-endotracheal suction which will be conducted after the intervention period, as specified above, and during a patient rest period before and after intervention. Both interventions will be conducted for ten minutes each, twice daily, for fourteen days.
Population: After receiving consent to participate in the study from a guardian,15 adults aged 30-75, diagnosed with DOC, hospitalized in prolonged respiratory department will participate.
Tools: Physiological signs, behavioral pain scale, Modify Ashworth Scale, Brain Engagement Index.
Expected Results:
- Statistical significance will be found between measurements prior to interventions (control) and after interventions, both during rest (clinical pain) and during medical procedures, in the following measures:
- Physiological signs (blood pressure, pulse and respiratory indices) post intervention will be lower.
- Degree of spasticity post intervention will be lower.
- Pain levels post intervention will be lower.
- Statistical significance will be found in the levels of attention during interventions (sensory stimulations) in comparison to before the interventions (control), where the former will be higher in comparison to the latter.
- Statistical significance will be found in the efficiency of multi-sensory stimulations in comparison to a single sensory stimulation, where the former will show lower physiological signs, spasticity, and levels of pain during rest and medical procedures.
Findings may improve the quality of life in patients with respiratory distress, diagnosed with DOC, providing additional treatment options for pain management other than medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory stimulation | Experimental | Behavioral: Auditory stimulationExposing the patient to an audio-based stimulus. |
| Auditory and tactile stimulations | Experimental | Behavioral: Auditory and tactile stimulationsCombination of tactual and audio-based stimuli. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable vital and essential signs taken from a nurse report
- A score between 1-4 in Coma Near Coma scale.
Key exclusion criteria (7 listed)
- Spinal cord injury
- Past neurological disorders
- Past psychiatric disorders
- Pressure ulcers
- Prolonged fever
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 |
|---|---|---|
| Auditory stimulationThe patient will be exposed to music that he used to enjoy (from the family's or guardian's report) through headphones. In case no report is given, nature (brook) sounds will be streamed. | Behavioural | Auditory stimulation |
| Auditory and tactile stimulationsThe patient will be exposed to music that he used to enjoy (from the family's or guardian's report, otherwise nature (brook) music will be streamed) through headphones combined with deep tissue massage will be given on the upper limbs. | Behavioural | Auditory and tactile stimulations |
Primary outcome
Behavioral pain scale (BPS) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
BPS evaluates three behavioral domains (facial expressions, movement of upper limbs, and compliance with ventilation) that are based on observation of the patient body's posture and his response to a nociceptive stimulation. Each subscale is scored from 1 (no response) to 4 (full response). Therefore, possible BPS scores range from 3 (no pain) to 12 (maximum pain).
Modify Ashworth scale (MAS) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
MAS is used to measure the increase of muscle tone which is manifested by an increased resistance of joints to passive movement. The MAS measures on the following 6 level ordinal scale: 0 = no increased resistance; 1 = slightly increased resistance (catch followed by relaxation or minimal resistance at the end of the range of motion); 1+ = slightly increased resistance (catch followed by minimal resistance throughout less than half of the range of motion); 2 = clear resistance throughout most of the range of motion; 3 = strong resistance; passive movement is difficult; 4 = rigid flexion or extension.
EEG brainwave change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
EEG will be sampled using the Mind-Wave dry electrode system, with one frontal electrode and one reference electrode on the earlobe, at a sampling rate of 512Hz. Positioning of the electrode conforms with the goal of monitoring prefrontal activity, which may correlate with attention regardless of the site of lesion. The sampled data is transferred through a wireless connection to the computer, where the Brain Engagement Index (BEI) is processed in real-time every 10 seconds and presented by the BEI monitor.
Respiratory Rate (RR) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
The set ventilatory rate is the minimum number of breaths delivered to the patient per minute. The actual rate may be higher than the set rate if the patient is initiating spontaneous breaths. Rate is also a determinant of ventilation and is adjusted in response to the patient's CO2 (carbon dioxide) levels. RR will be collected from the patient's respiratory machine.
Tidal Volume (TV) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Tidal volume (TV) is the volume of gas delivered to the patient with each breath. Tidal volume may also be expressed as TV. TV is only set for volume-controlled modes of ventilation and is usually 8-12cc/kg of body weight. TV will be collected from the patient's respiratory machine.
Peak Inspiratory Pressure (PIP) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Inspiratory pressure reflects global alveolar pressure and is monitored continuously. The maximum allowable PIP is set on the ventilator. If the PIP exceeds the set value, an alarm will sound, and gas delivery will halt until the next breath is triggered. The normal peak inspiratory pressure on a mechanically ventilated patient with normal lungs is approximately 20cm H2O (water). The maximum allowable peak pressure varies from patient to patient. The pulmonologists determine the safest pressure for each patient. PIP values should be trended in volume-controlled modes to detect changes in pulmonary compliance. PIP will be collected from the patient's respiratory machine.
Systolic Blood Pressure (SBP) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
SBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Cross-sectional values for systolic blood pressure: norm 120-129, normal-high 130-139, and hypertension ≥140. SBP will be collected using a monitoring equipment located in the departments.
Diastolic Blood Pressure (DBP) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
DBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Optimal diastolic blood pressure values <80, with cross-sectional points to norm 80-84, normal-high 85-89, and hypertension ≥90. DBP will be collected using a monitoring equipment located in the departments.
Heart Rate (HR) change
Time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
HR will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. The average pulse value is 60-80 beats per minute. HR will be collected using a monitoring equipment located in the departments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients.Link provided by the sponsor.
- Pain measurement techniques: Spotlight on mechanically ventilated patients.Link provided by the sponsor.
- Comparison of Single and Combined Effects of Nature Sounds and Foot Sole Reflexology Massage on the Level of Consciousness in Traumatic Comatose PatientsLink provided by the sponsor.
- Suctioning: A review of current research recommendationsLink provided by the sponsor.
- The effects of massage and music on pain, anxiety and relaxation in burn patients: Randomized controlled clinical trialLink provided by the sponsor.
- The effect of sensory stimulation provided by family on arterial blood oxygen saturation in critical care patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be available upon personal request
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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. This study is not recruiting at the moment.
Shely Farag Harpak, B.O.T study chair
Tel Aviv University
Yoseph Mishal, Dr. principal investigator
Bet Hadar- Medical rehabilitation and nursing center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory stimulation and Auditory and tactile stimulations in people with Disorder of Consciousness, run by Tel Aviv University at 1 site in Israel.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral pain scale (BPS) change (time frame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14). The study lists 9 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 18 Nov 2023.