Clinical trial NCT02026986: Sleep Deprivation Reduces Tear Secretion and Impairs the Tear Film
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: References

1. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:75-92.
2. Johnson ME, Murphy PJ. Changes in the tear film and ocular surface from dry eye syndrome. Prog Retin Eye Res. 2004;23:449-474.
3. Giacomo Savini, Pinita Prabhawasat, Takashi Kojima, Martin Grueterich, Edgar Espana, Eiki Goto. The challenge of dry eye diagnosis. Clin Ophthalmol. 2008; 2: 31-55.
4. Kamperis K, Hagstroem S, Radvanska E, Rittig S, Djurhuus JC. Excess diuresis and natriuresis during acute sleep deprivation in healthy adults. Am J Physiol Renal Physiol. 2010;299:F404-F411.
5. Mahler B, Kamperis K, Schroeder M, Frøkiær J, Djurhuus JC, Rittig S. Sleep deprivation induces excess diuresis and natriuresis in healthy children. Am J Physiol Renal Physiol. 2012;302:F236-F243.
6. McEwen BS. Sleep deprivation as a neurobiologic and physiologic stressor: Allostasis and allostatic load. Metabolism. 2006;55(10 Suppl 2):S20-S23.
7. Nascimento DC, Andersen ML, Hipólide DC, Nobrega JN, Tufik S. Pain hypersensitivity induced by paradoxical sleep deprivation is not due to altered binding to brain mu-opioid receptors. Behav Brain Res. 2007;178:216-220.
8. Everson CA. Functional consequences of sustained sleep deprivation in the rat. Behavioural Brain Research. 1995;69:43-54.
9. Kim JH, Kim JH, Nam WH, Yi K, Choi DG, Hyon JY, Wee WR, Shin YJ. Oral alcohol administration disturbs tear film and ocular surface. Ophthalmology. 2012;119:965-71.
10. Leproult R, Copinschi G, Buxton O, Van Cauter E. Sleep loss results in an elevation of cortisol levels the next evening. Sleep 1997;20:865-870.
11. Dartt DA. Neural regulation of lacrimal gland secretory processes: relevance in dry eye diseases. Prog Retin Eye Res. 2009;28:155-177.
12. The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:93-107.

Eligibility criteria: Inclusion Criteria:

* Twenty healthy young male volunteers aged 20-30 years

Exclusion Criteria:

* •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.

Primary outcomes:
measure: Tear osmolarity measurement
timeFrame: 1 day
Secondary outcomes:
measure: Visual analog pain score
timeFrame: 1 day
measure: Tear break up time
timeFrame: 1 day
measure: Intraocular pressure
timeFrame: 1 day
measure: Schirmer's test
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul,
country: Korea, Republic of
facility: Hallym University, Kangnam Sacred Heart Hospital
Study officials:
affiliation: Hallym University
name: Young Joo Shin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.