Coronary Artery DiseaseANC-RANCT07707843
AI ANC Headphones in Rotational Atherectomy
A study testing AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6) in people with Coronary Artery Disease, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Background: Rotational atherectomy (RA) generates high-intensity drilling noise concentrated around 3000 Hz, creating a distinctive auditory stressor that may exacerbate perioperative anxiety and autonomic dysregulation in patients undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2026to 30 Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Angiographically confirmed severe coronary calcification requiring RA under local anesthesia.
- Whisper test passed, confirming adequate communication ability.
- Clear consciousness with Mini-Mental State Examination (MMSE) score >= 27.
- Voluntary participation with written informed consent.
Who cannot join
- Moderate-to-severe hearing impairment or bilateral ear conditions precluding headphone use.
- Severe neurological disease or history of psychiatric disorders.
- Emergency surgery, cardiogenic shock, or extreme preoperative hemodynamic instability.
- Use of sedatives or anxiolytics within 24 hours before the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Noise Cancellation Headphones on Anxiety and Autonomic Function During Rotational Atherectomy: A Randomized Trial
Background: Rotational atherectomy (RA) generates high-intensity drilling noise concentrated around 3000 Hz, creating a distinctive auditory stressor that may exacerbate perioperative anxiety and autonomic dysregulation in patients undergoing percutaneous coronary intervention. Despite growing evidence linking procedural noise to adverse psychological and physiological outcomes, targeted noise-reduction interventions in the cardiac catheterization laboratory remain unexplored.
Aims: To investigate the effects of intraoperative artificial intelligence-enabled active noise cancellation (AI ANC) headphones on state anxiety, autonomic nerve function assessed by heart rate variability (HRV), and hemodynamic stability in patients undergoing RA.
Methods: This prospective, randomized, assessor-blinded, controlled trial enrolled 100 patients undergoing elective RA between January and June 2026 at a tertiary hospital in Shandong Province, China. After screening 120 consecutive patients, 100 eligible participants were randomized 1:1 to the experimental group (AI ANC headphones [Sony WH-1000XM6] plus standard care, n=50) or the control group (standard care alone, n=50). The primary outcome was the change in state anxiety (S-AI) score from baseline to post-procedure. Secondary outcomes included noise disturbance visual analogue scale (VAS), patient satisfaction, HRV indices (time-domain: SDNN, RMSSD; frequency-domain by autoregressive [AR] model and fast Fourier transform [FFT] as reference), hemodynamic fluctuations (MAP, HR, SpO2), incidence of symptomatic coronary spasm, and intraoperative vasodilator consumption. Continuous ECG was recorded via Polar H10 chest strap; HRV was analyzed using Kubios HRV Scientific 4.3. All analyses followed the intention-to-treat principle.
- Conditions
- Coronary Artery Disease
- Being tested
- AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6)
- Keywords
- Active noise cancellation, Anxiety, Heart rate variability, Perioperative nursing, Hemodynamic stability, Randomized controlled trial
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6)Device
Commercially available over-ear ANC headphones with adaptive AI-driven noise cancellation and voice-passthrough mode. Set to ANC mode throughout the procedure. A palm placed on the right earcup temporarily activates conversation mode; releasing the hand restores full noise cancellation.
| Study group | Role | What they receive |
|---|---|---|
| AI ANC Headphones + Standard Care | Experimental | Both groups receive standardized perioperative nursing care and RA procedural protocols. In addition, patients in the experimental arm: (a) undergo pre-procedure education explaining the headphone's dual function (noise filtering + speech preservation); (b) immediately before RA initiation, a trained nurse fits the patient with Sony WH-1000XM6 headphones set to ANC mode and verifies comfort; (c) the headphones remain in place throughout the entire procedure; (d) intraoperatively, if communication difficulty arises, the nurse places their palm on the right earcup to temporarily activate conversation mode - releasing the hand restores full noise cancellation; (e) contingency: if communication remains inadequate or patient intolerance/device malfunction occurs, headphones are immediately removed (patient stays in ITT analysis). All patients wear a Polar H10 chest-strap heart rate monitor (1000 Hz sampling) for continuous ECG recording during RA. Receives: Device: AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6) |
| Standard Care Alone | No intervention | Patients receive full, identical standardized perioperative nursing care and RA procedural protocols as the experimental arm, including verbal reassurance from the circulating nurse using standardized neutral language (to minimize performance bias). Patients wear the Polar H10 chest-strap heart rate monitor for continuous ECG recording. No noise-cancelling headphones are used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Score from Baseline to Post-Procedure (S-AI Change Score)
State anxiety is assessed using the state subscale of the Chinese version of the State-Trait Anxiety Inventory (STAI Form Y; Spielberger et al., 1983). The S-AI comprises 20 items each rated on a 4-point Likert scale (total score range: 20-80), with higher scores indicating greater state anxiety. Internal consistency (Cronbach's alpha) = 0.83-0.93. The scale is administered at two time points: Baseline (T0) - after admission to the preoperative area and before initiation of rotational atherectomy; Post-procedure (T1) - after sheath removal and before leaving the catheterization laboratory. The primary metric is the change score: delta S-AI = T1 minus T0 (negative values indicate anxiety reduction).
Measured: baseline (pre-procedure) and immediately after the procedure
Secondary outcomes (9)
Perceived Noise Disturbance on Visual Analogue Scale (VAS)
immediately after the procedure, the patient rates: "How disturbing was the procedural noise?" on a 1-10 horizontal VAS (1 = not disturbing at all; 10 = extremely disturbing)
Measured: immediately after the procedure
Overall Procedural Satisfaction on Visual Analogue Scale (VAS)
immediately after the procedure, the patient rates overall satisfaction with the procedural experience on a 1-10 VAS (1 = completely dissatisfied; 10 = completely satisfied).
Measured: immediately after the procedure
Standard Deviation of Normal-to-Normal R-R Intervals (SDNN) During Rotational Atherectomy
Continuous beat-to-beat R-R interval data (at least 5 minutes) recorded throughout the Rotational Atherectomy procedure using the Polar H10 chest strap (sampling rate: 1000 Hz). Raw data analyzed using Kubios HRV Scientific version 4.3 (Kubios Oy, Kuopio, Finland) with automatic artefact correction at the 'Very Low' threshold. SDNN reflects overall autonomic regulatory capacity.
Measured: during the rotational atherectomy procedure
Root Mean Square of Successive R-R Interval Differences (RMSSD) During Rotational Atherectomy
Calculated from the same at-least-5-minute R-R interval recording using Kubios HRV Scientific 4.3. RMSSD specifically captures vagally mediated beat-to-beat modulation of heart rate.
Measured: during the rotational atherectomy procedure
High-Frequency (HF) Power and Low-Frequency/High-Frequency (LF/HF) Ratio by Autoregressive (AR) Spectral Analysis During Rotational Atherectomy
Frequency-domain analysis performed using AR modeling (primary method, 16th-order model) and FFT (reference method, Welch's periodogram). HF power (0.15-0.40 Hz, ms2) primarily reflects respiratory-mediated vagal efferent activity. VLF power excluded per Task Force recommendations. Bonferroni correction (adjusted alpha = 0.00625) applied to frequency-domain indices.
Measured: during the rotational atherectomy procedure
Maximum Mean Arterial Pressure (MAP) Fluctuation Amplitude During Rotational Atherectomy
MAP monitored continuously via radial arterial sheath. Maximum fluctuation amplitude = maximum MAP minus minimum MAP during the RA procedure (mmHg).
Measured: during the rotational atherectomy procedure
Maximum Heart Rate (HR) Fluctuation Amplitude During Rotational Atherectomy
HR derived from continuous three-lead electrocardiography. Maximum fluctuation amplitude = maximum HR minus minimum HR (bpm). Mean HR and minimum/maximum HR also reported.
Measured: during the rotational atherectomy procedure
Incidence of Symptomatic Coronary Artery Spasm During Rotational Atherectomy
Defined as transient coronary lumen narrowing greater than 50 percent compared to baseline angiography, accompanied by chest pain and/or ST-segment changes, requiring vasodilator administration.
Measured: during the rotational atherectomy procedure
Cumulative Intraoperative Dose of Vasodilator Agents (Nitroglycerin, Adenosine)
Total administered dose (micrograms) of nitroglycerin and/or adenosine during the RA procedure, abstracted from the procedural medication record.
Measured: during the rotational atherectomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start9 Jan 2026
- Primary completion26 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Parallel groups
- Model description
- Prospective, single-center, parallel-group, assessor-blinded, randomized controlled trial. Participants are randomized 1:1 to the experimental arm (AI ANC headphones plus standard care) or the control arm (standard care alone) using computer-generated block randomization (block sizes of 4 and 6) with sequentially numbered, opaque, sealed envelopes for allocation concealment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707843
- Sponsor's protocol ID
- KYLL-2026-03-013
- Acronym
- ANC-RA
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Noise Cancellation Headphones on Anxiety and Autonomic Function During Rotational Atherectomy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07707843
- Acronym / sponsor ID
- ANC-RA / KYLL-2026-03-013
- Conditions
- Coronary Artery Disease
- Keywords
- Active noise cancellation, Anxiety, Heart rate variability, Perioperative nursing, Hemodynamic stability, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 16 Jul 2026 (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.
Background: Rotational atherectomy (RA) generates high-intensity drilling noise concentrated around 3000 Hz, creating a distinctive auditory stressor that may exacerbate perioperative anxiety and autonomic dysregulation in patients undergoing percutaneous coronary intervention. Despite growing evidence linking procedural noise to adverse psychological and physiological outcomes, targeted noise-reduction interventions in the cardiac catheterization laboratory remain unexplored.
Aims: To investigate the effects of intraoperative artificial intelligence-enabled active noise cancellation (AI ANC) headphones on state anxiety, autonomic nerve function assessed by heart rate variability (HRV), and hemodynamic stability in patients undergoing RA.
Methods: This prospective, randomized, assessor-blinded, controlled trial enrolled 100 patients undergoing elective RA between January and June 2026 at a tertiary hospital in Shandong Province, China. After screening 120 consecutive patients, 100 eligible participants were randomized 1:1 to the experimental group (AI ANC headphones [Sony WH-1000XM6] plus standard care, n=50) or the control group (standard care alone, n=50). The primary outcome was the change in state anxiety (S-AI) score from baseline to post-procedure. Secondary outcomes included noise disturbance visual analogue scale (VAS), patient satisfaction, HRV indices (time-domain: SDNN, RMSSD; frequency-domain by autoregressive [AR] model and fast Fourier transform [FFT] as reference), hemodynamic fluctuations (MAP, HR, SpO2), incidence of symptomatic coronary spasm, and intraoperative vasodilator consumption. Continuous ECG was recorded via Polar H10 chest strap; HRV was analyzed using Kubios HRV Scientific 4.3. All analyses followed the intention-to-treat principle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-center, parallel-group, assessor-blinded, randomized controlled trial. Participants are randomized 1:1 to the experimental arm (AI ANC headphones plus standard care) or the control arm (standard care alone) using computer-generated block randomization (block sizes of 4 and 6) with sequentially numbered, opaque, sealed envelopes for allocation concealment.
| Arm | Type | Receives |
|---|---|---|
| AI ANC Headphones + Standard Care | Experimental | Device: AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6)Both groups receive standardized perioperative nursing care and RA procedural protocols. In addition, patients in the experimental arm: (a) undergo pre-procedure education explaining the headphone's dual function (noise filtering + speech preservation); (b) immediately before RA initiation, a trained nurse fits the patient with Sony WH-1000XM6 headphones set to ANC mode and verifies comfort; (c) the headphones remain in place throughout the entire procedure; (d) intraoperatively, if communication difficulty arises, the nurse places their palm on the right earcup to temporarily activate conversation mode - releasing the hand restores full noise cancellation; (e) contingency: if communication remains inadequate or patient intolerance/device malfunction occurs, headphones are immediately removed (patient stays in ITT analysis). All patients wear a Polar H10 chest-strap heart rate monitor (1000 Hz sampling) for continuous ECG recording during RA. |
| Standard Care Alone | No intervention | –Patients receive full, identical standardized perioperative nursing care and RA procedural protocols as the experimental arm, including verbal reassurance from the circulating nurse using standardized neutral language (to minimize performance bias). Patients wear the Polar H10 chest-strap heart rate monitor for continuous ECG recording. No noise-cancelling headphones are used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years.
- Angiographically confirmed severe coronary calcification requiring RA under local anesthesia.
- Whisper test passed, confirming adequate communication ability.
- Clear consciousness with Mini-Mental State Examination (MMSE) score >= 27.
- Voluntary participation with written informed consent.
Key exclusion criteria (4 listed)
- Moderate-to-severe hearing impairment or bilateral ear conditions precluding headphone use.
- Severe neurological disease or history of psychiatric disorders.
- Emergency surgery, cardiogenic shock, or extreme preoperative hemodynamic instability.
- Use of sedatives or anxiolytics within 24 hours before the procedure.
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 |
|---|---|---|
| AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6)Commercially available over-ear ANC headphones with adaptive AI-driven noise cancellation and voice-passthrough mode. Set to ANC mode throughout the procedure. A palm placed on the right earcup temporarily activates conversation mode; releasing the hand restores full noise cancellation. | Device | AI ANC Headphones + Standard Care |
Primary outcome
Change in State Anxiety Score from Baseline to Post-Procedure (S-AI Change Score)
Time frame: baseline (pre-procedure) and immediately after the procedure
State anxiety is assessed using the state subscale of the Chinese version of the State-Trait Anxiety Inventory (STAI Form Y; Spielberger et al., 1983). The S-AI comprises 20 items each rated on a 4-point Likert scale (total score range: 20-80), with higher scores indicating greater state anxiety. Internal consistency (Cronbach's alpha) = 0.83-0.93. The scale is administered at two time points: Baseline (T0) - after admission to the preoperative area and before initiation of rotational atherectomy; Post-procedure (T1) - after sheath removal and before leaving the catheterization laboratory. The primary metric is the change score: delta S-AI = T1 minus T0 (negative values indicate anxiety reduction).
9 secondary outcomes
Perceived Noise Disturbance on Visual Analogue Scale (VAS)
Time frame: immediately after the procedure
Overall Procedural Satisfaction on Visual Analogue Scale (VAS)
Time frame: immediately after the procedure
Standard Deviation of Normal-to-Normal R-R Intervals (SDNN) During Rotational Atherectomy
Time frame: during the rotational atherectomy procedure
Root Mean Square of Successive R-R Interval Differences (RMSSD) During Rotational Atherectomy
Time frame: during the rotational atherectomy procedure
High-Frequency (HF) Power and Low-Frequency/High-Frequency (LF/HF) Ratio by Autoregressive (AR) Spectral Analysis During Rotational Atherectomy
Time frame: during the rotational atherectomy procedure
Maximum Mean Arterial Pressure (MAP) Fluctuation Amplitude During Rotational Atherectomy
Time frame: during the rotational atherectomy procedure
Maximum Heart Rate (HR) Fluctuation Amplitude During Rotational Atherectomy
Time frame: during the rotational atherectomy procedure
Incidence of Symptomatic Coronary Artery Spasm During Rotational Atherectomy
Time frame: during the rotational atherectomy procedure
Cumulative Intraoperative Dose of Vasodilator Agents (Nitroglycerin, Adenosine)
Time frame: during the rotational atherectomy procedure
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 16 Jul 2026.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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 AI-Powered Active Noise-Cancelling Headphones (Sony WH-1000XM6) in people with Coronary Artery Disease, run by Qilu Hospital of Shandong University at 1 site in China.
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 5 inclusion and 4 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 16 Jul 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 China. 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?
Change in State Anxiety Score from Baseline to Post-Procedure (S-AI Change Score) (time frame: baseline (pre-procedure) and immediately after the procedure). 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 16 Jul 2026.