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IRCT20250902067089N3 IRCT 2026-11-07 Tehran University of Medical Sciences Effects of clear blue-light-filtering glasses compared with anti-reflective glasses on sleep timing and sleep quality Effects of Clear Blue-Light–Filtering Versus Anti-Reflective Coated Lenses on Sleep Timing and Sleep Quality: A Triple-Masked, Randomized Crossover Clinical Trial 2027-01-01 anticipated 24 Pending https://irct.ir/trial/94120 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Other design features: Two-period, two-sequence crossover design. Each participant receives both lens conditions for 10 consecutive days each, separated by a 10-day washout. Study spectacles are worn from 6:00 PM until bedtime. Both lens conditions use identical frames, the same optical prescription, and visually matched anti-reflective coatings. The total intervention and washout duration is 30 days per participant, Randomization description: The unit of randomization is the individual participant. After eligibility confirmation and baseline assessment, 24 participants will be randomly allocated in a 1:1 ratio to the A-to-B or B-to-A lens sequence, with 12 participants per sequence. An independent researcher will generate the allocation sequence using computer-generated permuted blocks of four, without stratification. This researcher will not participate in recruitment, outcome assessment, data entry, or statistical analysis. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by the independent researcher. After enrolment, the next envelope will be opened by the unblinded lens dispenser to assign the coded lens sequence, Blinding description: Participants, the outcome examiner, and the statistician will remain blinded to the identity of the study lenses. An independent researcher will code the clear blue-light-filtering and conventional anti-reflective lenses as Lens A and Lens B and retain the confidential code. Both lens types will be mounted in identical frames, have the same optical prescription, and be matched as closely as possible in material, refractive index, visible-light transmission, and surface appearance, including the same visible violet residual reflection of the anti-reflective coating. The unblinded researcher responsible for preparing and dispensing the coded lenses will not participate in recruitment, outcome assessment, data entry, or statistical analysis. At the end of each intervention period, participants and the outcome examiner will independently guess the lens identity and rate their confidence to assess masking success. The lens-identity code will be released only after database lock and completion of the final statistical analysis, except when emergency unmasking is required for participant safety. N/A Sleep timing and sleep quality in adults who habitually use digital devices after sunset. Intervention 1: Intervention group: Clear blue-light-filtering spectacle lenses worn daily from 6:00 PM until bedtime for 10 consecutive days. In this crossover trial, each participant receives both the blue-light-filtering lenses and the conventional anti-reflective coated comparator lenses in a randomly assigned order, separated by a 10-day washout period. The two pairs of spectacles are matched for prescription, frame, lens material and refractive index, visible light transmission, and appearance. During washout, the study spectacles are not worn; ordinary clear spectacles without blue-light filtering may be used if refractive correction is required. Intervention 2: Control group: Conventional clear anti-reflective coated spectacle lenses without a blue-light-filtering feature, worn daily from 6:00 PM until bedtime for 10 consecutive days. Each participant receives this comparator and the blue-light-filtering lenses in a randomly assigned order, separated by a 10-day washout period. The two pairs of spectacles are matched for prescription, frame, lens material and refractive index, visible light transmission, and appearance. During washout, the study spectacles are not worn; ordinary clear spectacles without blue-light filtering may be used if refractive correction is required. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The research team has not yet made a final decision regarding the sharing of deidentified individual participant data.
public Masoud Khorrami Nejad
School of Rehabilitation, Tehran University of Medical Sciences, Safi Alishah Street Corner, Shimiran Junction, Enghelab Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 Dr.khorraminejad@gmail.com Tehran University of Medical Sciences scientific Masoud Khorrami Nejad
School of Rehabilitation, Tehran University of Medical Sciences, Safi Alishah Street Corner, Shimiran Junction, Enghelab Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 Dr.khorraminejad@gmail.com Tehran University of Medical Sciences Iraq Age 18–40 years. Ability to understand study procedures and provide written informed consent. Habitual digital-device use for at least one hour after sunset on at least five evenings per week. Stable habitual sleep schedule during the preceding month, with bedtime and wake time varying by no more than two hours on most days. Willingness to wear each assigned study lens from 6:00 PM until bedtime for 10 consecutive days and complete the 10-day washout period. Willingness to complete the daily sleep diary, exposure log, adherence record, and adverse-effect form. Normal or corrected-to-normal visual acuity and no clinically significant ocular disease affecting visual function. No uncontrolled systemic, psychiatric, or neurological condition likely to affect sleep or participation. Agreement to maintain usual sleep habits, evening activities, caffeine intake, and digital-device use throughout the study. 18 years 40 years Both Self-reported physician-diagnosed sleep disorder, including chronic insomnia, delayed sleep–wake phase disorder, obstructive sleep apnoea, restless legs syndrome, or narcolepsy. Current night-shift or rotating-shift employment. Travel across more than two time zones during the previous month or planned during the study. Current use of melatonin, hypnotics, sedatives, stimulants, or other medications or supplements known to substantially affect sleep or circadian rhythms. Uncontrolled psychiatric, neurological, endocrine, cardiovascular, or systemic disease that could influence sleep. Significant ocular disease, uncorrectable reduced visual acuity, severe colour-vision deficiency, or ocular surgery during the previous three months. Current use of tinted, photochromic, or blue-light-filtering spectacles that cannot be discontinued during the intervention periods. Hazardous alcohol use, defined as more than 14 standard drinks per week, or recreational drug use. Participation in another clinical study that could influence sleep outcomes. Inability or unwillingness to comply with the lens-wearing schedule or complete the required records. Treatment - Devices Treatment - Devices Intervention group: Clear blue-light-filtering spectacle lenses worn daily from 6:00 PM until bedtime for 10 consecutive days. In this crossover trial, each participant receives both the blue-light-filtering lenses and the conventional anti-reflective coated comparator lenses in a randomly assigned order, separated by a 10-day washout period. The two pairs of spectacles are matched for prescription, frame, lens material and refractive index, visible light transmission, and appearance. During washout, the study spectacles are not worn; ordinary clear spectacles without blue-light filtering may be used if refractive correction is required. Control group: Conventional clear anti-reflective coated spectacle lenses without a blue-light-filtering feature, worn daily from 6:00 PM until bedtime for 10 consecutive days. Each participant receives this comparator and the blue-light-filtering lenses in a randomly assigned order, separated by a 10-day washout period. The two pairs of spectacles are matched for prescription, frame, lens material and refractive index, visible light transmission, and appearance. During washout, the study spectacles are not worn; ordinary clear spectacles without blue-light filtering may be used if refractive correction is required. Mean nightly sleep onset time during each lens condition, expressed as minutes elapsed from 6:00 PM. Timepoint: Recorded each morning for the preceding night throughout both 10-day intervention periods (study nights 1–10 and 21–30), and averaged separately for each lens condition. Method of measurement: Daily sleep diary recording the participant-reported estimated clock time of falling asleep in 24-hour format. Clock times are converted to minutes elapsed from 6:00 PM to account for sleep onset after midnight. Mean nightly subjective sleep quality score during each lens condition, measured on a scale from 0 to 10, with higher scores indicating better sleep quality. Timepoint: Each morning for the preceding night during study nights 1–10 and 21–30, with scores averaged separately for each intervention period. Method of measurement: Participant self-report in the daily sleep diary, rating the preceding night's sleep quality from 0 (worst sleep quality) to 10 (best sleep quality). Mean sleep onset latency during each lens condition, expressed in minutes. Timepoint: Each morning for the preceding night during study nights 1–10 and 21–30, with values averaged separately for each intervention period. Method of measurement: Participant self-report in the daily sleep diary of the time taken to fall asleep after attempting to sleep, recorded in minutes. Mean nightly total sleep time during each lens condition, expressed in minutes. Timepoint: Each morning for the preceding night during study nights 1–10 and 21–30, with values averaged separately for each intervention period. Method of measurement: Calculated from participant-reported daily sleep diary entries as the interval between sleep onset and final awakening, minus the total time spent awake during that interval, expressed in minutes. Mean sleep efficiency during each lens condition, expressed as a percentage. Timepoint: Each morning for the preceding night during study nights 1–10 and 21–30, with values averaged separately for each intervention period. Method of measurement: Calculated from participant-reported daily sleep diary entries as total sleep time divided by time in bed, multiplied by 100. Mean final morning awakening time during each lens condition. Timepoint: Each morning for the preceding night during study nights 1–10 and 21–30, with values averaged separately for each intervention period. Method of measurement: Participant self-report in the daily sleep diary of the clock time of final morning awakening, recorded in 24-hour format. Mean wake after sleep onset during each lens condition, expressed in minutes. Timepoint: Each morning for the preceding night during study nights 1–10 and 21–30, with values averaged separately for each intervention period. Method of measurement: Participant self-report in the daily sleep diary of the total time spent awake after initial sleep onset and before final awakening, recorded in minutes. Pittsburgh Sleep Quality Index global score, ranging from 0 to 21, with higher scores indicating poorer sleep quality. Timepoint: At baseline and at the end of each 10-day intervention period, on study days 10 and 30. Method of measurement: Self-administered Pittsburgh Sleep Quality Index using the standard one-month recall period at baseline and a modified recall period covering the corresponding 10-day intervention at each post-intervention assessment, as specified in the protocol. The global score is calculated by summing the seven component scores. Mean percentage adherence to study spectacle wear during each intervention period. Timepoint: Daily during study days 1–10 and 21–30, with percentage adherence averaged separately for each intervention period. Method of measurement: Calculated from participant-reported spectacle donning and removal times and non-wear interruptions in the daily exposure and adherence log. Adherence equals actual wear time divided by prescribed wear time from 6:00 PM until bedtime, multiplied by 100. Frequency, type, and severity of adverse effects and visual complaints during each study lens condition. Timepoint: Recorded daily during study days 1–10 and 21–30 and reviewed at the end of each intervention period, on days 10 and 30. Method of measurement: Participant self-report in the daily exposure and adherence log, reviewed by the researcher using the end-of-intervention evaluation form. Adverse effects are recorded by presence and type, including visual discomfort, headache, visual disturbance, colour-perception complaints, or other effects, with severity classified as mild, moderate, or severe. Tehran University of Medical Sciences Approved 2026-10-08 Research Ethics Committee, School of Nursing and Midwifery & Rehabilitation, TUMS Dr. Mirkhani Street (East Nosrat), Towhid Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)