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Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment

Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005458
Enrollment
Unknown
Registered
2014-11-10
Start date
2014-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

ICU sleep deprivation

Interventions

ICU noise and light group:simulated ICU noise and light
earplugs and eyemasks group:wearing earplugs and eyemasks

Sponsors

Fuzhou Children's Hospital of Fujian Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 70 Years

Inclusion criteria

Inclusion criteria: Subjects were included in the study if they were older than 18 years of age, body mass index (BMI) less than 26 kg/m2, non-smoker, had scores of 7 or less on the Pittsburgh Sleep Quality Index (PSQI), usually went to bed between 9 pm and midnight and had habitual time in bed between 6 and 9 hours per night.

Exclusion criteria

Exclusion criteria: Exclusion criteria included a history or current diagnosis of other sleep disorders (such as restless leg syndrome, periodic leg movements with arousals, narcolepsy, rapid eye movement (REM) Behavior Disorder, circadian rhythm sleep disorder, breathing related sleep disorder, or parasomnias), reduced hearing acuity (more than 20-dB hearing loss at a single frequency, as tested with audiometer Entomed SA 201) and blindness, a history of alcohol or medication abuse. Participants with an occupational history that included shift work or recent significant travel across three or more time zones within the prior two weeks were also excluded. In addition, after a screening PSG, participants with an apnea-hypopnea index more than 15 or a periodic leg movement arousal index more than 15 and known allergy to melatonin were also excluded.

Design outcomes

Primary

MeasureTime frame
total sleep time;NREM stage1;NREM stage 2;SWS;REM;arousal index;subjective sleep quality;anxiety level;

Contacts

Public ContactShen Ling
vivian198543@163.com+86 13705038829

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026