We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.NCT02026986
Sleep Deprivation Reduces Tear Secretion and Impairs the Tear Film
A study testing sleep deprivation in people with We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface., run by Hallym University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.
- What is being tested?
- sleep deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Twenty healthy young male volunteers aged 20-30 years
Who cannot join
- •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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University, Kangnam Sacred Heart Hospital
Seoul, 150-950
About this study
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.
Read the detailed description
References
- 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.
- Johnson ME, Murphy PJ. Changes in the tear film and ocular surface from dry eye syndrome. Prog Retin Eye Res. 2004;23:449-474.
- Giacomo Savini, Pinita Prabhawasat, Takashi Kojima, Martin Grueterich, Edgar Espana, Eiki Goto. The challenge of dry eye diagnosis. Clin Ophthalmol. 2008; 2: 31-55.
- 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.
- 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.
- McEwen BS. Sleep deprivation as a neurobiologic and physiologic stressor: Allostasis and allostatic load. Metabolism. 2006;55(10 Suppl 2):S20-S23.
- 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.
- Everson CA. Functional consequences of sustained sleep deprivation in the rat. Behavioural Brain Research. 1995;69:43-54.
- 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.
- 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.
- Dartt DA. Neural regulation of lacrimal gland secretory processes: relevance in dry eye diseases. Prog Retin Eye Res. 2009;28:155-177.
- The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:93-107.
- Being tested
- sleep deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep deprivationBehavioural
sleep deprivation for one night
| Study group | Role | What they receive |
|---|---|---|
| sleep deprivation | Experimental | Ten subjects in the SD group were examined after a SD experiment in which they did not sleep for 24 h. Receives: Behavioral: sleep deprivation |
| control | No intervention | The 10 subjects in the control group were not sleep deprived (had 8 h of sleep). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (4)
Visual analog pain score
Visual analog pain score Subjective discomfort or pain was graded numerically using the VAS. The scale range was 0 (absence of pain) to 10 (maximal pain). Subjects were asked to describe their symptoms using the VAS.
Measured: 1 day
Tear break up time
Fluorescein was placed in the lower conjunctival sac using a fluorescein strip (HAAG-STREIT, Köniz, Switzerland), and the time between the last blink and the first appearance of a dark spot was measured using the cobalt blue light of a slit lamp. This procedure was repeated 3 times, and the average value was recorded.
Measured: 1 day
Intraocular pressure
Intraocular pressure was measured by noncontact tonometer (CT-80, Topcon Corp., Tokyo, Japan). Intraocular pressure expressed in millimeters of mercury (mm Hg).
Measured: 1 day
Schirmer's test
One drop of 0.5% proparacaine hydrochloride (Alcaine, Alcon, Forth Worth, TX, USA) was instilled in the conjunctival sac for topical anesthesia. In a silent room, filter paper (Color Bar, EagleVision, Memphis, TN, USA) was placed in the inferolateral one-third of the lower lid. Care was taken to prevent the paper from contacting the cornea. After 5 minutes, the level of strip wetting (in millimeters) was measured.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joo Shin, Hallym University Medical Center
- Investigators
- Young Joo Shin, Principal investigator, Hallym University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026986
- Sponsor's protocol ID
- 20131231
- Status last verified
- Jan 2014
- First submitted
- 2 Jan 2014
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24833736
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Deprivation Reduces Tear Secretion and Impairs the Tear Film
- ClinicalTrials.gov ID
- NCT02026986
- Acronym / sponsor ID
- 20131231
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Johnson ME, Murphy PJ. Changes in the tear film and ocular surface from dry eye syndrome. Prog Retin Eye Res. 2004;23:449-474.
- Giacomo Savini, Pinita Prabhawasat, Takashi Kojima, Martin Grueterich, Edgar Espana, Eiki Goto. The challenge of dry eye diagnosis. Clin Ophthalmol. 2008; 2: 31-55.
- 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.
- 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.
- McEwen BS. Sleep deprivation as a neurobiologic and physiologic stressor: Allostasis and allostatic load. Metabolism. 2006;55(10 Suppl 2):S20-S23.
- 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.
- Everson CA. Functional consequences of sustained sleep deprivation in the rat. Behavioural Brain Research. 1995;69:43-54.
- 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.
- 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.
- Dartt DA. Neural regulation of lacrimal gland secretory processes: relevance in dry eye diseases. Prog Retin Eye Res. 2009;28:155-177.
- The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:93-107.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep deprivation | Experimental | Behavioral: sleep deprivationTen subjects in the SD group were examined after a SD experiment in which they did not sleep for 24 h. |
| control | No intervention | –The 10 subjects in the control group were not sleep deprived (had 8 h of sleep). |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Twenty healthy young male volunteers aged 20-30 years
Key exclusion criteria (3 listed)
- •Subjects with dry eye symptoms within the previous 6 months were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep deprivationsleep deprivation for one night | Behavioural | sleep deprivation |
Primary outcome
Tear osmolarity measurement
Time frame: 1 day
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).
4 secondary outcomes
Visual analog pain score
Time frame: 1 day
Tear break up time
Time frame: 1 day
Intraocular pressure
Time frame: 1 day
Schirmer's test
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
- Derived from this study: PubMed 24833736Lee 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Joo Shin principal investigator
Hallym University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep deprivation in people with We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface., run by Hallym University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear osmolarity measurement (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02026986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.