💬In plain words
What the trial is, and whether it could suit you
This study is a multicenter, single-arm, prospective clinical trial designed to observe the long-term safety and effectiveness of the digital medical device BELL-001 in patients diagnosed with insomnia. Insomnia is a common sleep disorder that can significantly affect daytime functioning, mood, and overall quality of life. Many patients continue to experience difficulties despite lifestyle modifications or pharmacological treatment, and there is a growing need for safer, non-pharmacological therapeutic options.
BELL-001 is a smartphone-based therapeutic device that delivers personalized auditory stimulation during the pre-sleep period. The device is designed to promote relaxation and support the transition into sleep by analyzing individual breathing patterns and providing synchronized sound feedback. This study evaluates the long-term safety and effectiveness of BELL-001 over approxima
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Diagnosed with ICD-10 nonorganic insomnia (F51.0) or sleep initiation and maintenance disorder (insomnia, G47.0)
* Insomnia Severity Index (ISI) score ≥ 15
* Adults aged 19 to 75 years
* Capable of using a smartphone or tablet and has access to a stable internet connection
* Willing to provide written informed consent voluntarily and able to comply with all study procedures
* Agrees not to initiate any other insomnia treatment other than cognitive behavioral therapy for insomnia during the trial
* Has completed sleep diary entries for at least 3 out of 7 days from the day after the screening visit through the day of the baseline visit (Visit 2)
* At the baseline visit (Visit 2), sleep diary data from the preceding 7 days confirms at least 3 nights with a sleep onset latency of 30 minutes or more, or wake after sleep onset of 60 minutes or more
Exclusion Criteria:
* Individuals with severe psychiatric disorders, including major depressive disorder
* Individuals diagnosed with or suspected of having insomnia comorbid with narcolepsy (G47.4), obstructive sleep apnea (G47.30), restless legs syndrome (G25.81), periodic limb movement disorder (G47.61), or REM sleep behavior disorder (G47.52) per ICD-10-CM codes
* Individuals with active physical illness or unstable medical conditions that interfere with activities of daily living, including congestive heart failure, chronic obstructive pulmonary disease (COPD), acute pain, cerebrovascular disease (e.g., stroke), or neurodegenerative disorders (e.g., dementia, multiple sclerosis)
* Individuals whose insomnia symptoms are considered to be caused or exacerbated by the physiological effects of medications (prescription drugs or substances of abuse) or alcohol
* Individuals deemed by the investigator to be unable to participate in the study due to respiratory conditions such as asthma
* Individuals with moderate or greater hearing loss in both ears
* Individuals suspected of sleep medication dependence at the investigator's discretion
* Individuals with a history of change in the type or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within 4 weeks prior to the baseline visit (Visit 2)
* Individuals currently reporting persistent tinnitus symptoms
* Individuals diagnosed with shift work sleep-wake disorder, or those who experience periodic insomnia or sleep-wake rhythm disturbance due to a work environment requiring repeated circadian readjustment, such as day/night shift rotation or frequent international travel
* Individuals who took PRN (as-needed) sleep medications during the screening period (including the day before Visit 1)
* Individuals who used other investigational drugs or investigational digital medical devices within 3 months prior to Visit 1 I-ndividuals with prior experience using BELL-001
* Individuals deemed inappropriate for participation in the clinical trial by the investigator for any other reason
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