Spatial Audio StimulationNCT06919497
NOICE vs. Nothing | Thermode
A study testing Spatial audio stimulation and No spatial audio stimulation in people with Spatial Audio Stimulation, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to test whether the non-visual immersive technologies, which uses spatial audio simulation, can help people better tolerate heat pain. As a proof-of-concept study, study team will use the NOICE device. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Audio Stimulation
- What is being tested?
- Spatial audio stimulation and No spatial audio stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Sep 2027
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 years and older
- English-speaking
- Intact hearing
- No self-reported or clinically diagnosed acute or chronic medical conditions that affect safe participation
Who cannot join
- Use chronotropic heart medications
- Use pain medications
- Current hearing loss
- Currently taking beta blockers, or opioids or other prescription pain medications
- History of chronic pain or acute pain syndromes
- Current hearing loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: NOICE vs. Nothing | Thermode: A Prospective, Randomized, Crossover Study
The purpose of this study is to test whether the non-visual immersive technologies, which uses spatial audio simulation, can help people better tolerate heat pain. As a proof-of-concept study, study team will use the NOICE device. This research is not studying the NOICE device specifically and the device is not a medical device.
Read the detailed description
This study addresses the research gap in understanding how spatial audio impacts pain perception, specifically heat pain, in clinical settings. It is important to explore this because spatial audio may serve as a non-pharmaceutical, immersive alternative to traditional visual-based distraction methods like virtual reality.
The investigators hypothesize that participants using the spatial audio simulation device will report an increased heat pain threshold compared to not using the device. This knowledge could improve information on the perception of pain for participant who prefer not to use VR headsets.
- Conditions
- Spatial Audio Stimulation
- Being tested
- Spatial audio stimulation, No spatial audio stimulation
- Keywords
- Thermal Sensory Analyzer (TSA-II), Peltier-Based Contact Thermode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial audio stimulationBehavioural
Study RA will affix the thermode to the dorsum of the participant's dominant or non-dominant hand. Participants will undergo heat-pain-inducing thermode exposure. The intervention will be randomized to receive spatial audio stimulation or not for the first HPT trial, then crossed over to the other study condition for the second HPT trial.
Participants will be randomized to expose their dominant or non-dominant hand first. Between each levels test, the thermode will be moved to the other hand (ex: VR: DH, NDH, DH; Nothing: NDH, DH, NDH). There will be a 30 second break between each levels test and a five-minute washout period between each intervention.
No spatial audio stimulationBehavioural
Study RA will affix the thermode to the dorsum of the participant's dominant or non-dominant hand. Participants will undergo heat-pain-inducing thermode exposure. The intervention will be randomized to receive spatial audio stimulation or not for the first HPT trial, then crossed over to the other study condition for the second HPT trial.
Participants will be randomized to expose their dominant or non-dominant hand first. Between each levels test, the thermode will be moved to the other hand (ex: VR: DH, NDH, DH; Nothing: NDH, DH, NDH). There will be a 30 second break between each levels test and a five-minute washout period between each intervention.
| Study group | Role | What they receive |
|---|---|---|
| Spatial audio stimulation | Experimental | Participant will receive spatial audio stimulation first and then will not receive spatial audio stimulation in the latter part of the study. Receives: Behavioral: Spatial audio stimulation; Behavioral: No spatial audio stimulation |
| No spatial audio stimulation | Experimental | Participant will not receive spatial audio stimulation first and then will receive spatial audio stimulation in the latter part of the study. Receives: Behavioral: Spatial audio stimulation; Behavioral: No spatial audio stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heat pain threshold
Heat pain threshold measured by the TSA Air II device. Temperature ranges from 32 degrees C to 44 degrees C, with higher temperatures indicating a higher heat pain threshold.
Measured: Duration of intervention, approximately 15 minutes
Secondary outcomes (5)
Change in heat pain sensitivity (HPS)
To evaluate heat pain sensitivity(HPS), participants will complete the Numerical Rating Pain Scale (NRPS) immediately following each trial, where they rank pain sensitivity on an ordinal scale from 0 = no pain to 10 = worst pain possible under both treatment conditions.
Measured: immediately after intervention
Anxiety Level
participants will complete the Visual Analog Scale for Measuring Anxiety (VAS-A) immediately following each group of levels tests, where they will rank anxiety scores on a sliding scale from 0 = No anxiety/fear to 100 = Worst possible anxiety/fear
Measured: immediately after intervention
ISO Ergonomic scale
The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
Measured: immediately after intervention
System Usability Scale (SUS) Score
The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
Measured: immediately after intervention
Device satisfaction
To evaluate the overall impact of device satisfaction of the spatial audio stimulation device, participants will complete the Patient Technology Satisfaction Survey. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = completely.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Why it stopped: The investigator has no intention to initiate the study at this moment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial Audio StimulationStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919497
- Sponsor's protocol ID
- 80078
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOICE vs. Nothing | Thermode: A Prospective, Randomized, Crossover Study
- ClinicalTrials.gov ID
- NCT06919497
- Acronym / sponsor ID
- 80078
- Conditions
- Spatial Audio Stimulation
- Keywords
- Thermal Sensory Analyzer (TSA-II), Peltier-Based Contact Thermode
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigator has no intention to initiate the study at this moment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Apr 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.
The purpose of this study is to test whether the non-visual immersive technologies, which uses spatial audio simulation, can help people better tolerate heat pain. As a proof-of-concept study, study team will use the NOICE device. This research is not studying the NOICE device specifically and the device is not a medical device.
Detailed description
This study addresses the research gap in understanding how spatial audio impacts pain perception, specifically heat pain, in clinical settings. It is important to explore this because spatial audio may serve as a non-pharmaceutical, immersive alternative to traditional visual-based distraction methods like virtual reality.
The investigators hypothesize that participants using the spatial audio simulation device will report an increased heat pain threshold compared to not using the device. This knowledge could improve information on the perception of pain for participant who prefer not to use VR headsets.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spatial audio stimulation | Experimental | Behavioral: Spatial audio stimulation, Behavioral: No spatial audio stimulationParticipant will receive spatial audio stimulation first and then will not receive spatial audio stimulation in the latter part of the study. |
| No spatial audio stimulation | Experimental | Behavioral: Spatial audio stimulation, Behavioral: No spatial audio stimulationParticipant will not receive spatial audio stimulation first and then will receive spatial audio stimulation in the latter part of the study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 years and older
- English-speaking
- Intact hearing
- No self-reported or clinically diagnosed acute or chronic medical conditions that affect safe participation
Key exclusion criteria (6 listed)
- Use chronotropic heart medications
- Use pain medications
- Current hearing loss
- Currently taking beta blockers, or opioids or other prescription pain medications
- History of chronic pain or acute pain syndromes
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 |
|---|---|---|
| Spatial audio stimulationStudy RA will affix the thermode to the dorsum of the participant's dominant or non-dominant hand. Participants will undergo heat-pain-inducing thermode exposure. The intervention will be randomized to receive spatial audio stimulation or not for the first HPT trial, then crossed over to the other study condition for the second HPT trial. Participants will be randomized to expose their dominant or non-dominant hand first. Between each levels test, the thermode will be moved to the other hand (ex: VR: DH, NDH, DH; Nothing: NDH, DH, NDH). There will be a 30 second break between each levels test and a five-minute washout period between each intervention. | Behavioural | No spatial audio stimulation, Spatial audio stimulation |
| No spatial audio stimulationStudy RA will affix the thermode to the dorsum of the participant's dominant or non-dominant hand. Participants will undergo heat-pain-inducing thermode exposure. The intervention will be randomized to receive spatial audio stimulation or not for the first HPT trial, then crossed over to the other study condition for the second HPT trial. Participants will be randomized to expose their dominant or non-dominant hand first. Between each levels test, the thermode will be moved to the other hand (ex: VR: DH, NDH, DH; Nothing: NDH, DH, NDH). There will be a 30 second break between each levels test and a five-minute washout period between each intervention. | Behavioural | No spatial audio stimulation, Spatial audio stimulation |
Primary outcome
Change in heat pain threshold
Time frame: Duration of intervention, approximately 15 minutes
Heat pain threshold measured by the TSA Air II device. Temperature ranges from 32 degrees C to 44 degrees C, with higher temperatures indicating a higher heat pain threshold.
5 secondary outcomes
Change in heat pain sensitivity (HPS)
Time frame: immediately after intervention
Anxiety Level
Time frame: immediately after intervention
ISO Ergonomic scale
Time frame: immediately after intervention
System Usability Scale (SUS) Score
Time frame: immediately after intervention
Device satisfaction
Time frame: immediately after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Spatial Audio Stimulation
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 Spatial audio stimulation and No spatial audio stimulation in people with Spatial Audio Stimulation, run by Stanford University 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 28 Oct 2026. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in heat pain threshold (time frame: Duration of intervention, approximately 15 minutes). 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 28 Oct 2026.