NCT02026986

Brief Summary

Tear film consists of three layers including outer lipid layer, aqueous layer and inner mucin layer.1,2 Lipid layer protects the aqueous layer of tear film from evaporation and mucin layer adhere the tear film to ocular surface. Aqueous layer, which is produced in lacrimal glands, is the most important in the health of ocular surface. Reduction of aqueous tear secretion results in the disruption of homeostasis at ocular surface and leads to dry eye syndrome.2 Dry eye syndrome is a common ocular surface disease associated with symptoms of eye discomfort, grittness and visual disturbance.1,2 Dry eye syndrome disrupts normal homeostasis at the ocular surface resulting in epithelial damage, epithelial cell apoptosis, loss of goblet cells, and squamous metaplasia.1-3 The changes and inflammation of ocular surface subsequently lead to tear instability, which causes an increased tear osmolarity and aggravates the inflammatory cascades. This leads to a vicious cycle.2 The regulation of tear film secretion is under neural and hormonal control.4 Dry eye syndrome has been associated with diverse and multiple causes, including depressive disorder, drugs, hormonal status, and systemic diseases.2 Sleep deprivation (SD) is known to cause profound impair¬ments in executive function and vigilant attention.5,6 It is also reportedly associated with autonomic and endocrine functioning7-9 and has been shown to increase blood pressure and stress hormone levels and decrease parasympathetic tone.10,11 Tear secretion is regulated by neurological factors and hormones,12 and so SD may have an effect on the tear film and ocular surface. However, only a few studies have evaluated the effect of sleep on the tear film and ocular surface. In this study, we investigated the effect of SD on the tear film and ocular surface.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

January 2, 2014

Last Update Submit

January 2, 2014

Conditions

We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.

Outcome Measures

Primary Outcomes (1)

  • Tear osmolarity measurement

    A microcapillary glass tube (Marienfeld, Lauda-Königshofen, Germany) was placed on the lower outer conjunctival sac. To avoid reflex tearing, the subjects were asked to direct their gaze supranasally. A total of 30 µL of tears was taken from the marginal tear strip. After centrifugation at 3000 rpm for 3 min, supernatants were obtained and the samples were stored at -80 degree. Tear osmolarity was measured using a Multi-OSMETTE 2430 (Precision Systems Inc., Natick, MA, USA).

    1 day

Secondary Outcomes (4)

  • Visual analog pain score

    1 day

  • Tear break up time

    1 day

  • Intraocular pressure

    1 day

  • Schirmer's test

    1 day

Study Arms (2)

sleep deprivation

EXPERIMENTAL

Ten subjects in the SD group were examined after a SD experiment in which they did not sleep for 24 h.

Behavioral: sleep deprivation

control

NO INTERVENTION

The 10 subjects in the control group were not sleep deprived (had 8 h of sleep).

Interventions

sleep deprivationBEHAVIORAL

sleep deprivation for one night

sleep deprivation

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Twenty healthy young male volunteers aged 20-30 years

You may not qualify if:

  • Subjects with dry eye symptoms within the previous 6 months were excluded from the study.
  • Subjects have any systemic diseases such as systemic lupus, rheumatoid arthritis, Sjögren's syndrome or a history of ocular disease.
  • Subjects have disorder of lid margin, nasolacrimal duct, and cornea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University, Kangnam Sacred Heart Hospital

Seoul, 150-950, South Korea

Location

Related Publications (1)

  • Lee YB, Koh JW, Hyon JY, Wee WR, Kim JJ, Shin YJ. Sleep deprivation reduces tear secretion and impairs the tear film. Invest Ophthalmol Vis Sci. 2014 May 15;55(6):3525-31. doi: 10.1167/iovs.14-13881.

    PMID: 24833736DERIVED

Study Officials

  • Young Joo Shin

    Hallym University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 3, 2014

Study Start

December 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

KR(1)