Effects of Personalized Auditory Stimulation on Sleep Quality

Efficacy Validation of Sleep Induction Using Closed-Loop Auditory Cardiac Pacing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012083

Enrollment

Registered

2026-06-05

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Closed-loop auditory cardiac pacing) : Participants undergo experimental (Condition A) and control (Condition B) conditions in a randomized order with a 1-week washout. - Condition A (Exper

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged between 19 and 65 years (inclusive), regardless of gender 2. Individuals with complaints of subjective sleep disturbances or difficulties initiating sleep 3. Individuals who provide written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients with severe tinnitus (such as pulsatile tinnitus) or hyperacusis 2. Patients with severe obstructive sleep apnea currently on CPAP therapy or with a history of sleep apnea surgery 3. Individuals with severe arrhythmia, such as atrial fibrillation, making heart rate variability (HRV) measurement impossible 4. Hearing-impaired individuals unable to perceive auditory stimuli 5. Pregnant women 6. Individuals who refuse to provide written informed consent 7. Personnel in a professional subordinate relationship with the investigators

Design outcomes

Primary

Measure	Time frame
Wake time after sleep onset (WASO) measured by polysomnography;Sleep onset latency (SOL) measured by polysomnography	—

Secondary

Measure	Time frame
Total sleep time (TST), sleep efficiency (SE), sleep stage proportions (proportions of N1, N2, N3, and REM sleep), and REM sleep latency;Arousal Index, Apnea-Hypopnea Index (AHI), Apnea Index (AI), Hypopnea Index (HI), and Respiratory Disturbance Index (RDI);Heart rate variability (HRV) frequency-domain parameters and pre- to post-sleep changes in subjective symptom questionnaire scores	—

Countries

Korea, Republic of

Contacts

Public ContactHyun Jun Kim

Ajou University Hospital

entkhj@ajou.ac.kr+82-31-219-5265

Outcome results