Psychomotor SpeedNCT07165899
Effects of Exposure to a Single-electrode Electroencephalography-guided Binaural Beat Audio Track on Sustained Attention and Subjective Well-being Among Healthy Adults
A study testing EEG-Guided Binaural Beat Audio in people with Psychomotor Speed and Sustained Attention, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
This study aims to explore the potential of binaural beats, adjusted in real-time via EEG feedback, to positively influence brain states related to relaxation, focus, and cognitive performance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Speed, Sustained Attention, Inhibitory Control
- What is being tested?
- EEG-Guided Binaural Beat Audio
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 26 Nov 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female adults (age > 18 years)
Who cannot join
- Cognitive impairment (self-reported)
- Gross visual, auditory, or motor impairments; severe physical, psychiatric, or neurological impairments
- History of epilepsy, seizures, or seizure-like episodes
- History of intracranial lesions, stroke, traumatic brain injury, neoplasms, cranial surgery, or foreign bodies
- Current daily alcohol or substance abuse
- Current daily use of medications affecting EEG activity (e.g., anti-epileptics, opioids) or lowering seizure threshold
- Self-reported auditory hypersensitivity or prior adverse effects from audio stimulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center, Lubbock, TX, USA
Lubbock, Texas, 79430
About this study
Official title: Effects of Exposure to a Single-electrode Electroencephalography-guided Binaural Beat Audio Track on Sustained Attention and Subjective Well-being Among Healthy Adults: a Randomized, Double-blinded, Sham-controlled Repeated-measures Crossover Trial
This study aims to explore the potential of binaural beats, adjusted in real-time via EEG feedback, to positively influence brain states related to relaxation, focus, and cognitive performance. The investigators are examining how these auditory techniques can improve memory, attention, and overall subjective well-being.
Read the detailed description
With the existence of a strong evidence base regarding audio-assisted relaxation, audio products are widely used globally to achieve relaxed and focused mental states. The utility of audio for achieving relaxed mental states has revolutionized with the advent of the concept of binaural beats, an auditory phenomenon that is induced by separately presenting two tones of different frequencies to each ear. The superior olivary nucleus of the midbrain computes the difference between the two tones, and with time, the brain state is expected to synchronize with the difference in the frequencies presented to the two ears. Binaural beats are widely used to achieve relaxed mental states for applications including improved memory, enhanced relaxation, augmented hypnotherapy, improved sleep quality, creating and breaking habits, addiction therapy, and enhanced cognitive performance with limited empirical support.
Electroencephalography (EEG) is a well-established technique for recording the electrical activity of the brain. This is conventionally achieved through the placement of multiple electrodes across the scalp, allowing for the detection of the brain's spontaneous electrical activity over a period of time. EEG measures voltage fluctuations resulting from ionic current flows within the neurons of the brain. Single-electrode electroencephalography simplifies the conventional approach by using one electrode placed at a strategic location on the scalp. When recorded over the pre-frontal cortex, this method allows for capturing the electrical activity of the brain's frontal lobe, which is responsible for high-level cognitive functions and behavior. EEG waves are typically divided into bandwidths known as frequency bands. These are characterized based on their frequency, which is measured in cycles per second (Hz), and include:
Delta waves (0 to 4 Hz): Associated with deep sleep and certain pathological conditions.
Theta waves (4.1 to 8 Hz): Linked to drowsiness, early stages of sleep, and meditation.
Low Alpha waves (8.1 to 10 Hz): Related to relaxed, calm, and resting states. High Alpha waves (10.1 to 14 Hz): Often associated with a state of wakeful relaxation.
Low beta waves (14.1-20 Hz): Associated with arousal, active thought, concentration, complex thought High beta waves (20.1-32 Hz): Associated with heightened arousal, hyperactive thought, hypervigilance, and states of anxiety/panic While the brain produces all of these wave types simultaneously, typically, one frequency band is dominant at any given time, reflecting the predominant brain state. For instance, during deep sleep, delta waves predominate, while during active concentration, beta waves are more prominent.
The Frequency-Following Response (FFR) is a neurophysiological mechanism where brain EEG activity synchronizes with auditory frequency stimuli. This synchronization is particularly evident with binaural beats. While many studies have supported the notion that binaural beats, via FFR, can induce desired brain states that are particularly for relaxation (e.g., increased high alpha activity), increased receptivity for hypnotic suggestions (e.g., heightened low alpha or theta activity), as well as induce sleep and improve the quality of sleep. However, other studies have challenged this notion, supported by not observing a significant FFR when the brains were stimulated for a duration of < 5 minutes with one binaural beat frequency falling within a particular band at a given time. In fact, delivering binaural beats to participants, regardless of their current brain state, could result in discomfort, headaches, and dizziness.
The proposed study aims to overcome this limited efficacy of a static binaural beat frequency in eliciting an FFR by guiding the delivered binaural beat frequency with real-time feedback obtained from a single-electrode EEG. Based on the current biological understanding of FFR, the investigators propose to conduct a randomized, double-blinded, sham-controlled repeated-measures crossover trial to answer the following research questions:
- Can a dynamic binaural beat frequency implemented with single-electrode EEG guidance elicit an FFR to guide the predominant EEG frequency of an individual to a target low alpha state?
- Can a target low-alpha state achieved with the EEG feedback be sustained while the binaural beats are delivered at the target low-alpha frequency?
- Will guiding the brain to the low-alpha state and maintaining it for up to 15 minutes in the target low-alpha state be associated with improvements in
- subjective perception of relaxation, sleepiness, focus, performance on cognitive tasks, and overall well-being
- objectively measured speed of reacting to stimuli, attention, inhibitory control (i.e., decreased impulsivity), and better memory encoding in a stop-signal reaction task
- objective performance in a Go-No-Go task
- objective performance in a graded novelty encoding task
- Being tested
- EEG-Guided Binaural Beat Audio, Sham Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-Guided Binaural Beat AudioBehavioural
30-minute audio session with dynamic frequency adjustments based on real-time EEG feedback
Sham ControlBehavioural
30-minute audio session with identical tones presented to both ears (no binaural beat), EEG monitored but not used for frequency adjustment
| Study group | Role | What they receive |
|---|---|---|
| EEG-Guided Binaural Beat Audio | Experimental | 30-minute audio session with dynamic frequency adjustments based on real-time EEG feedback Receives: Behavioral: EEG-Guided Binaural Beat Audio |
| Sham Control | Sham comparator | 30-minute audio session with identical tones presented to both ears, EEG monitored but not used for frequency adjustment Receives: Behavioral: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop Signal Reaction Time
Estimated time (milliseconds) required to inhibit a prepotent response following a stop signal, derived from the integration method. Lower values indicate better inhibitory control.
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 10 minutes after completion of session).
Reaction Time on Novelty Encoding Task
Mean response latency (seconds) during the novelty encoding task recognition phase. Lower values indicate faster information retrieval and decision speed without implying a speed-accuracy trade-off. The unit of measurement is in seconds.
Measured: Baseline (at visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Predominant Frequency and Frequency Band from a Single Prefrontal Electrode
EEG data were segmented into epochs and subjected to quality control procedures. For each epoch, sample entropy was calculated as a measure of signal irregularity. Epochs with entropy values above the 75th percentile were classified as high-noise and excluded from further analysis. The remaining epochs were standardized by z-scoring, transformed to the frequency domain, and then summarized into standard bands (delta: 0.5-4 Hz, theta: 4-8 Hz, low-alpha: 8-10 Hz, high-alpha: 10-12 Hz, low-beta: 12-18 Hz, high-beta: 18-32 Hz) to facilitate comparison across participants and conditions.
Measured: The duration of the audio intervention was 30 minutes. Predominant frequency and frequency bands were measured as baseline, 5, 10, 15, 20, 25 minutes, and at the end of the session (at 30 minutes).
Secondary outcomes (7)
Visual Analogue Scale - Subjective Relaxation
Self-reported relaxation, rated on a visual analogue scale (0-100; higher scores indicate greater relaxation).
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Sleepiness
100 mm VAS, anchored at 0 ("Fully awake") and 100 ("Extremely sleepy"). Higher scores = greater sleepiness.
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Focus
100 mm VAS, anchored at 0 ("Not focused at all") and 100 ("Extremely focused"). Higher scores = greater perceived focus.
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Cognitive Performance
100 mm VAS, anchored at 0 ("Very poor performance") and 100 ("Excellent performance"). Higher scores = better perceived cognitive performance.
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Overall Well-Being
100 mm VAS, anchored at 0 ("Very poor well-being") and 100 ("Excellent well-being"). Higher scores = better well-being.
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Hit Rate of Novelty Encoding Task
Proportion of targets correctly identified as "seen." Range 0-1; higher values indicate better recognition sensitivity. The unit of measurement is in proportion (0-1).
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
False Alarm Rate of Novelty Encoding Task
Proportion of non-targets incorrectly endorsed as "seen." Range 0-1; lower values indicate better discrimination (fewer false positives). The unit of measurement is in proportion (0-1).
Measured: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start16 Aug 2024
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor SpeedStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, sham-controlled, repeated-measures crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samudani Dhanasekara, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165899
- Sponsor's protocol ID
- IRB-FY2024-286
- Status last verified
- Sep 2025
- First submitted
- 14 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data may be shared with qualified researchers upon a reasonable request and after obtaining institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exposure to a Single-electrode Electroencephalography-guided Binaural Beat Audio Track on Sustained Attention and Subjective Well-being Among Healthy Adults: a Randomized, Double-blinded, Sham-controlled Repeated-measures Crossover Trial
- ClinicalTrials.gov ID
- NCT07165899
- Acronym / sponsor ID
- IRB-FY2024-286
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 10 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.
This study aims to explore the potential of binaural beats, adjusted in real-time via EEG feedback, to positively influence brain states related to relaxation, focus, and cognitive performance. The investigators are examining how these auditory techniques can improve memory, attention, and overall subjective well-being.
Detailed description
With the existence of a strong evidence base regarding audio-assisted relaxation, audio products are widely used globally to achieve relaxed and focused mental states. The utility of audio for achieving relaxed mental states has revolutionized with the advent of the concept of binaural beats, an auditory phenomenon that is induced by separately presenting two tones of different frequencies to each ear. The superior olivary nucleus of the midbrain computes the difference between the two tones, and with time, the brain state is expected to synchronize with the difference in the frequencies presented to the two ears. Binaural beats are widely used to achieve relaxed mental states for applications including improved memory, enhanced relaxation, augmented hypnotherapy, improved sleep quality, creating and breaking habits, addiction therapy, and enhanced cognitive performance with limited empirical support.
Electroencephalography (EEG) is a well-established technique for recording the electrical activity of the brain. This is conventionally achieved through the placement of multiple electrodes across the scalp, allowing for the detection of the brain's spontaneous electrical activity over a period of time. EEG measures voltage fluctuations resulting from ionic current flows within the neurons of the brain. Single-electrode electroencephalography simplifies the conventional approach by using one electrode placed at a strategic location on the scalp. When recorded over the pre-frontal cortex, this method allows for capturing the electrical activity of the brain's frontal lobe, which is responsible for high-level cognitive functions and behavior. EEG waves are typically divided into bandwidths known as frequency bands. These are characterized based on their frequency, which is measured in cycles per second (Hz), and include:
Delta waves (0 to 4 Hz): Associated with deep sleep and certain pathological conditions.
Theta waves (4.1 to 8 Hz): Linked to drowsiness, early stages of sleep, and meditation.
Low Alpha waves (8.1 to 10 Hz): Related to relaxed, calm, and resting states. High Alpha waves (10.1 to 14 Hz): Often associated with a state of wakeful relaxation.
Low beta waves (14.1-20 Hz): Associated with arousal, active thought, concentration, complex thought High beta waves (20.1-32 Hz): Associated with heightened arousal, hyperactive thought, hypervigilance, and states of anxiety/panic While the brain produces all of these wave types simultaneously, typically, one frequency band is dominant at any given time, reflecting the predominant brain state. For instance, during deep sleep, delta waves predominate, while during active concentration, beta waves are more prominent.
The Frequency-Following Response (FFR) is a neurophysiological mechanism where brain EEG activity synchronizes with auditory frequency stimuli. This synchronization is particularly evident with binaural beats. While many studies have supported the notion that binaural beats, via FFR, can induce desired brain states that are particularly for relaxation (e.g., increased high alpha activity), increased receptivity for hypnotic suggestions (e.g., heightened low alpha or theta activity), as well as induce sleep and improve the quality of sleep. However, other studies have challenged this notion, supported by not observing a significant FFR when the brains were stimulated for a duration of < 5 minutes with one binaural beat frequency falling within a particular band at a given time. In fact, delivering binaural beats to participants, regardless of their current brain state, could result in discomfort, headaches, and dizziness.
The proposed study aims to overcome this limited efficacy of a static binaural beat frequency in eliciting an FFR by guiding the delivered binaural beat frequency with real-time feedback obtained from a single-electrode EEG. Based on the current biological understanding of FFR, the investigators propose to conduct a randomized, double-blinded, sham-controlled repeated-measures crossover trial to answer the following research questions:
- Can a dynamic binaural beat frequency implemented with single-electrode EEG guidance elicit an FFR to guide the predominant EEG frequency of an individual to a target low alpha state?
- Can a target low-alpha state achieved with the EEG feedback be sustained while the binaural beats are delivered at the target low-alpha frequency?
- Will guiding the brain to the low-alpha state and maintaining it for up to 15 minutes in the target low-alpha state be associated with improvements in
- subjective perception of relaxation, sleepiness, focus, performance on cognitive tasks, and overall well-being
- objectively measured speed of reacting to stimuli, attention, inhibitory control (i.e., decreased impulsivity), and better memory encoding in a stop-signal reaction task
- objective performance in a Go-No-Go task
- objective performance in a graded novelty encoding task
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, sham-controlled, repeated-measures crossover design
| Arm | Type | Receives |
|---|---|---|
| EEG-Guided Binaural Beat Audio | Experimental | Behavioral: EEG-Guided Binaural Beat Audio30-minute audio session with dynamic frequency adjustments based on real-time EEG feedback |
| Sham Control | Sham comparator | Behavioral: Sham Control30-minute audio session with identical tones presented to both ears, EEG monitored but not used for frequency adjustment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female adults (age > 18 years)
Key exclusion criteria (7 listed)
- Cognitive impairment (self-reported)
- Gross visual, auditory, or motor impairments; severe physical, psychiatric, or neurological impairments
- History of epilepsy, seizures, or seizure-like episodes
- History of intracranial lesions, stroke, traumatic brain injury, neoplasms, cranial surgery, or foreign bodies
- Current daily alcohol or substance abuse
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 |
|---|---|---|
| EEG-Guided Binaural Beat Audio30-minute audio session with dynamic frequency adjustments based on real-time EEG feedback | Behavioural | EEG-Guided Binaural Beat Audio |
| Sham Control30-minute audio session with identical tones presented to both ears (no binaural beat), EEG monitored but not used for frequency adjustment | Behavioural | Sham Control |
Primary outcome
Stop Signal Reaction Time
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 10 minutes after completion of session).
Estimated time (milliseconds) required to inhibit a prepotent response following a stop signal, derived from the integration method. Lower values indicate better inhibitory control.
Reaction Time on Novelty Encoding Task
Time frame: Baseline (at visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Mean response latency (seconds) during the novelty encoding task recognition phase. Lower values indicate faster information retrieval and decision speed without implying a speed-accuracy trade-off. The unit of measurement is in seconds.
Predominant Frequency and Frequency Band from a Single Prefrontal Electrode
Time frame: The duration of the audio intervention was 30 minutes. Predominant frequency and frequency bands were measured as baseline, 5, 10, 15, 20, 25 minutes, and at the end of the session (at 30 minutes).
EEG data were segmented into epochs and subjected to quality control procedures. For each epoch, sample entropy was calculated as a measure of signal irregularity. Epochs with entropy values above the 75th percentile were classified as high-noise and excluded from further analysis. The remaining epochs were standardized by z-scoring, transformed to the frequency domain, and then summarized into standard bands (delta: 0.5-4 Hz, theta: 4-8 Hz, low-alpha: 8-10 Hz, high-alpha: 10-12 Hz, low-beta: 12-18 Hz, high-beta: 18-32 Hz) to facilitate comparison across participants and conditions.
7 secondary outcomes
Visual Analogue Scale - Subjective Relaxation
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Sleepiness
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Focus
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Cognitive Performance
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Visual Analogue Scale - Overall Well-Being
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
Hit Rate of Novelty Encoding Task
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
False Alarm Rate of Novelty Encoding Task
Time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).
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 10 Sep 2025.
- Individual participant dataSharing planned: No. De-identified individual participant data may be shared with qualified researchers upon a reasonable request and after obtaining institutional approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-Guided Binaural Beat Audio in people with Psychomotor Speed and Sustained Attention, run by Texas Tech University Health Sciences Center at 1 site in United States.
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 1 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 10 Sep 2025. 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 United States. 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. 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?
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?
Stop Signal Reaction Time (time frame: Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 10 minutes after completion of session).). The study lists 3 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 10 Sep 2025.