Photobiomodulation for Reducing Sedative-Hypnotic Use:Clinical Trial of a Light-Therapy Device

NCT07764107 | Not Yet Recruiting DMC

• 1 other identifier: NHRI
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Insomnia is a prevalent and growing public health issue, with one in three adults affected globally and one in five Taiwanese adults reporting significant sleep disturbances. Long-term use of sedative-hypnotic medications remains common in Taiwan despite clinical guidelines recommending short-term use only, contributing to adverse outcomes such as impaired sleep architecture, cognitive deficits, and elevated dementia risk. Non-pharmacological interventions-particularly light-based therapies-offer promising alternatives but existing bright-light therapy is limited by melatonin suppression and the need for precise daytime timing. Recent advances in photobiomodulation (PBM) suggest that red and near-infrared light, which do not suppress melatonin, may enhance sleep quality and support glymphatic clearance when applied during sleep. Preliminary findings from our prior NSTC-funded industry-academia project demonstrated that 850-nm PBM applied during sleep improved subjective sleep quality and sleep duration among older adults with insomnia who were not using hypnotics. Building on these results, the present study aims to evaluate whether sleep-period PBM can improve sleep quality, enhance daytime alertness and cognitive function, and reduce sedative-hypnotic medication use among adults with chronic insomnia who regularly use these medications. Methods: The study will employ an 8-week, single-blind, randomized controlled trial with two parallel arms: (1) PBM intervention and (2) inactive sham control. We will develop an engineer-certified wearable PBM prototype integrating near-infrared LEDs. Sixty adults who use sedative-hypnotics ≥4 days per week will be recruited. Participants will be randomized in a 1:1 ratio and instructed to use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period. Outcomes will be assessed at baseline, week 4, and week 8. Primary outcomes include changes in subjective sleep quality (PSQI), hypnotic use frequency, and objective sleep parameters measured by wrist actigraphy. Secondary outcomes include daytime sleepiness (KSS), emotional symptoms (BDI and BAI), and psychomotor vigilance task performance. Expected contributions: This study is expected to generate clinical evidence in Taiwan evaluating nighttime PBM for insomnia in hypnotic-using populations, address the unmet need for portable, home-based, non-pharmacological sleep interventions, and support future commercialization of a sleep-compatible light therapy device. Results will inform device optimization, regulatory approval strategies, and market expansion efforts in the growing global sleep-health industry.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (3)

• Sleep quality

  Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).

  baseline, week 4, and week 8

• Hypnotic use frequency

  baseline, week 4, and week 8

• Actigraphy

  baseline, week 4, and week 8

Secondary Outcomes (1)

• Daytime sleepiness

  baseline, week 4, and week 8.

Study Arms (2)

PBM intervention

EXPERIMENTAL

Device: PBM intervention; Device: Inactive sham control

Inactive sham control

SHAM COMPARATOR

Device: Inactive sham control

Interventions

PBM intervention DEVICE

use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period

PBM intervention

Inactive sham control DEVICE

use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period

Inactive sham control; PBM intervention

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A Pittsburgh Sleep Quality Index (PSQI) score of 8 or above.
• Currently taking sedative-hypnotic medications at least 4 days per week.

You may not qualify if:

• Having a movement disorder, including Parkinson's disease or moderate to severe dementia, resulting in inability to ambulate independently.
• Having major psychiatric comorbidities, such as bipolar disorder or schizophrenia, or a Beck Depression Inventory-II (BDI-II) score greater than 13.
• A history of sleep disorders, such as obstructive sleep apnea or periodic limb movement disorder.
• Currently undergoing adjustment of sleep medications in clinical care.
• Skin damage or active dermatologic conditions at the irradiation site.
• Night-shift workers or individuals unable to maintain regular nighttime sleep for other reasons.
• Pregnant women.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Wan-Ju Cheng Ph.D

CONTACT

+886975682566; s871065@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-05