Sleep Disorders, Circadian RhythmNCT00387179
Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders
A study testing Melatonin, Methylxanthine and Light Therapy in people with Sleep Disorders, Circadian Rhythm, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Jet lag and some sleep disorders are caused by a disruption in an individual's "internal clock." Understanding the most effective way to quickly re-adjust the body's internal clock will be beneficial for treating individuals with these conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm
- What is being tested?
- Melatonin, Methylxanthine and Light Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Mar 2010
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health, as determined by blood chemistries, urine toxicology, physical examination, and medical and psychiatric history
Who cannot join
- History of any current or chronic disease, including any of the following:
- Chronobiologic disorders
- Sleep disorders
- Cardiovascular disorders
- Respiratory disorders
- Kidney and urinary tract disorders
Show all 17Show fewer
- Infectious diseases
- Gastrointestinal disorders
- Immune system disorders
- Connective tissue and joint disorders
- Hematopoietic disorders
- Neoplastic diseases
- Endocrine and metabolic diseases
- Neurologic disorders
- Current or past history of drug abuse
- Pregnant or breastfeeding
- Current oral contraceptive use
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sleep and Chronobiology Laboratory
Boulder, Colorado, 80309
Kenneth P. Wright, PhD
About this study
Official title: Circadian Integration of Photic and Non-photic Stimuli
Jet lag and some sleep disorders are caused by a disruption in an individual's "internal clock." Understanding the most effective way to quickly re-adjust the body's internal clock will be beneficial for treating individuals with these conditions. This study will evaluate the combined effectiveness of light and non-light therapies at regulating sleep cycles and improving sleep quality.
Read the detailed description
Circadian rhythm disorders are disruptions in an individual's circadian rhythm, or "internal body clock." This internal clock regulates the 24-hour cycle of biological processes in the body, including sleep and hormone production. Jet lag, delayed sleep phase syndrome, in which individuals fall asleep and wake up later than desired, and advanced sleep phase syndrome, in which individuals fall asleep and wake up earlier than desired, are all examples of circadian rhythm disorders. Because of the disruptive nature of these conditions, it is important to identify the quickest and most effective method for regulating the body and reestablishing normal sleep patterns. Light therapy, in which individuals are exposed to bright, artificial light, is currently used to treat these disorders. Melatonin, a hormone that regulates circadian rhythms, and methylxanthines, a class of stimulant medications, are other common non-light treatments. While each of these individual treatments has been proven effective, little is known about the combined effect of light and non-light treatments. The purpose of this study is to evaluate the safety and effectiveness of light therapy, melatonin, and methylxanthine, alone and in combination, at regulating circadian rhythms and improving sleep quality and cognitive function.
This study will enroll healthy individuals. Participants will first attend two screening visits, which will include a review of medical, psychiatric, and sleep histories; vital sign measurements; blood and urine collection; a physical examination; and an electrocardiogram. For 1 week, participants will record sleep habits in a diary and by telephone. They will also wear a device that monitors activity and light exposure levels. Eligible participants will then attend four 5-day inpatient visits at the Sleep and Chronobiology Laboratory at the University of Colorado at Boulder. During each of the four visits, participants will be randomly assigned to one of the following four treatments:
- Dim light therapy and placebo
- Bright light therapy and placebo
- Dim light therapy, melatonin, and methylxanthines
- Bright light therapy, melatonin, and methylxanthines
At each visit, participants will receive a different treatment. During these visits, participants will remain awake for up to 40 hours at a time, while their eye movements, and brain, muscle, heart, and breathing activity are monitored. Urine and saliva will be collected, and participants will undergo various cognitive performance testing measures. At 3-week intervals between each visit, participants will record sleep habits and will wear the activity and light exposure monitoring device. A sleep diary will also be maintained by participants for 3 weeks following the end of the last visit.
- Conditions
- Sleep Disorders, Circadian Rhythm
- Being tested
- Melatonin, Methylxanthine, Light Therapy
- Keywords
- Circadian Rhythm Sleep Disorders
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Life Extension Melatonin 5 mg
5mg, pill, once
MethylxanthineDrug
2.9 mg/kg, pill, once
Light TherapyProcedure or surgery
Bright light exposure
| Study group | Role | What they receive |
|---|---|---|
| Dim Light Melatonin and/or methylxanthine | Experimental | Dim Light Melatonin and/or methylxanthine Receives: Drug: Melatonin; Drug: Methylxanthine |
| Placebo and Dim Light or bright light | Experimental | Placebo and Dim Light or bright light Receives: Procedure: Light Therapy |
| Bright light melatonin and/or methylxanthine | Experimental | Bright light, melatonin, and/or methylxanthine Receives: Drug: Melatonin; Drug: Methylxanthine; Procedure: Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)
Measured: 24 hour
Secondary outcomes (3)
Circadian phase, as measured by the shift of the endogenous temperature rhythm
Measured: 24 hour
Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings
Measured: overnight
Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit)
Measured: 24 h and daytime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenneth P. Wright, PhD, Principal investigator, University of Colorado at Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387179
- Sponsor's protocol ID
- 406
- Other IDs
- M01RR000051, R01HL081761
- Status last verified
- Aug 2009
- First submitted
- 11 Oct 2006
- Last updated
- 25 Aug 2009
- Results posted
- No
Publications
Duffy JF, Wright KP Jr; New Collective Author. Entrainment of the human circadian system by light. J Biol Rhythms. 2005 Aug;20(4):326-38. doi: 10.1177/0748730405277983.
PubMed 16077152Wright KP Jr, Gronfier C, Duffy JF, Czeisler CA; New Collective Author. Intrinsic period and light intensity determine the phase relationship between melatonin and sleep in humans. J Biol Rhythms. 2005 Apr;20(2):168-77. doi: 10.1177/0748730404274265.
PubMed 15834113Gronfier C, Wright KP Jr, Kronauer RE, Jewett ME, Czeisler CA. Efficacy of a single sequence of intermittent bright light pulses for delaying circadian phase in humans. Am J Physiol Endocrinol Metab. 2004 Jul;287(1):E174-81. doi: 10.1152/ajpendo.00385.2003. Epub 2004 Mar 23.
PubMed 15039146Barger LK, Wright KP Jr, Hughes RJ, Czeisler CA; New Collective Author. Daily exercise facilitates phase delays of circadian melatonin rhythm in very dim light. Am J Physiol Regul Integr Comp Physiol. 2004 Jun;286(6):R1077-84. doi: 10.1152/ajpregu.00397.2003. Epub 2004 Mar 18.
PubMed 15031136Wright KP Jr, Czeisler CA. Absence of circadian phase resetting in response to bright light behind the knees. Science. 2002 Jul 26;297(5581):571. doi: 10.1126/science.1071697. No abstract available.
PubMed 12142528Wright KP Jr, Hughes RJ, Kronauer RE, Dijk DJ, Czeisler CA; New Collective Author. Intrinsic near-24-h pacemaker period determines limits of circadian entrainment to a weak synchronizer in humans. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):14027-32. doi: 10.1073/pnas.201530198.
PubMed 11717461Wright KP Jr, Myers BL, Plenzler SC, Drake CL, Badia P; New Collective Author. Acute effects of bright light and caffeine on nighttime melatonin and temperature levels in women taking and not taking oral contraceptives. Brain Res. 2000 Aug 11;873(2):310-7. doi: 10.1016/s0006-8993(00)02557-9.
PubMed 10930561Wright KP Jr, Badia P, Myers BL, Plenzler SC, Hakel M. Caffeine and light effects on nighttime melatonin and temperature levels in sleep-deprived humans. Brain Res. 1997 Jan 30;747(1):78-84. doi: 10.1016/s0006-8993(96)01268-1.
PubMed 9042530
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Integration of Photic and Non-photic Stimuli
- ClinicalTrials.gov ID
- NCT00387179
- Acronym / sponsor ID
- 406
- Conditions
- Sleep Disorders, Circadian Rhythm
- Keywords
- Circadian Rhythm Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 12 Oct 2006 (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.
Jet lag and some sleep disorders are caused by a disruption in an individual's "internal clock." Understanding the most effective way to quickly re-adjust the body's internal clock will be beneficial for treating individuals with these conditions. This study will evaluate the combined effectiveness of light and non-light therapies at regulating sleep cycles and improving sleep quality.
Detailed description
Circadian rhythm disorders are disruptions in an individual's circadian rhythm, or "internal body clock." This internal clock regulates the 24-hour cycle of biological processes in the body, including sleep and hormone production. Jet lag, delayed sleep phase syndrome, in which individuals fall asleep and wake up later than desired, and advanced sleep phase syndrome, in which individuals fall asleep and wake up earlier than desired, are all examples of circadian rhythm disorders. Because of the disruptive nature of these conditions, it is important to identify the quickest and most effective method for regulating the body and reestablishing normal sleep patterns. Light therapy, in which individuals are exposed to bright, artificial light, is currently used to treat these disorders. Melatonin, a hormone that regulates circadian rhythms, and methylxanthines, a class of stimulant medications, are other common non-light treatments. While each of these individual treatments has been proven effective, little is known about the combined effect of light and non-light treatments. The purpose of this study is to evaluate the safety and effectiveness of light therapy, melatonin, and methylxanthine, alone and in combination, at regulating circadian rhythms and improving sleep quality and cognitive function.
This study will enroll healthy individuals. Participants will first attend two screening visits, which will include a review of medical, psychiatric, and sleep histories; vital sign measurements; blood and urine collection; a physical examination; and an electrocardiogram. For 1 week, participants will record sleep habits in a diary and by telephone. They will also wear a device that monitors activity and light exposure levels. Eligible participants will then attend four 5-day inpatient visits at the Sleep and Chronobiology Laboratory at the University of Colorado at Boulder. During each of the four visits, participants will be randomly assigned to one of the following four treatments:
- Dim light therapy and placebo
- Bright light therapy and placebo
- Dim light therapy, melatonin, and methylxanthines
- Bright light therapy, melatonin, and methylxanthines
At each visit, participants will receive a different treatment. During these visits, participants will remain awake for up to 40 hours at a time, while their eye movements, and brain, muscle, heart, and breathing activity are monitored. Urine and saliva will be collected, and participants will undergo various cognitive performance testing measures. At 3-week intervals between each visit, participants will record sleep habits and will wear the activity and light exposure monitoring device. A sleep diary will also be maintained by participants for 3 weeks following the end of the last visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dim Light Melatonin and/or methylxanthine | Experimental | Drug: Melatonin, Drug: MethylxanthineDim Light Melatonin and/or methylxanthine |
| Placebo and Dim Light or bright light | Experimental | Procedure: Light TherapyPlacebo and Dim Light or bright light |
| Bright light melatonin and/or methylxanthine | Experimental | Drug: Melatonin, Drug: Methylxanthine, Procedure: Light TherapyBright light, melatonin, and/or methylxanthine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In good general health, as determined by blood chemistries, urine toxicology, physical examination, and medical and psychiatric history
Key exclusion criteria (17 listed)
- History of any current or chronic disease, including any of the following:
- Current or past history of drug abuse
- Pregnant or breastfeeding
- Current oral contraceptive use
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 |
|---|---|---|
| MelatoninAlso: Life Extension Melatonin 5 mg5mg, pill, once | Drug | Bright light melatonin and/or methylxanthine, Dim Light Melatonin and/or methylxanthine |
| Methylxanthine2.9 mg/kg, pill, once | Drug | Bright light melatonin and/or methylxanthine, Dim Light Melatonin and/or methylxanthine |
| Light TherapyBright light exposure | Procedure or surgery | Bright light melatonin and/or methylxanthine, Placebo and Dim Light or bright light |
Primary outcome
Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)
Time frame: 24 hour
3 secondary outcomes
Circadian phase, as measured by the shift of the endogenous temperature rhythm
Time frame: 24 hour
Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings
Time frame: overnight
Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit)
Time frame: 24 h and daytime
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Background: PubMed 16077152Duffy JF, Wright KP Jr; New Collective Author. Entrainment of the human circadian system by light. J Biol Rhythms. 2005 Aug;20(4):326-38. doi: 10.1177/0748730405277983.
- Background: PubMed 15834113Wright KP Jr, Gronfier C, Duffy JF, Czeisler CA; New Collective Author. Intrinsic period and light intensity determine the phase relationship between melatonin and sleep in humans. J Biol Rhythms. 2005 Apr;20(2):168-77. doi: 10.1177/0748730404274265.
- Background: PubMed 15039146Gronfier C, Wright KP Jr, Kronauer RE, Jewett ME, Czeisler CA. Efficacy of a single sequence of intermittent bright light pulses for delaying circadian phase in humans. Am J Physiol Endocrinol Metab. 2004 Jul;287(1):E174-81. doi: 10.1152/ajpendo.00385.2003. Epub 2004 Mar 23.
- Background: PubMed 15031136Barger LK, Wright KP Jr, Hughes RJ, Czeisler CA; New Collective Author. Daily exercise facilitates phase delays of circadian melatonin rhythm in very dim light. Am J Physiol Regul Integr Comp Physiol. 2004 Jun;286(6):R1077-84. doi: 10.1152/ajpregu.00397.2003. Epub 2004 Mar 18.
- Background: PubMed 12142528Wright KP Jr, Czeisler CA. Absence of circadian phase resetting in response to bright light behind the knees. Science. 2002 Jul 26;297(5581):571. doi: 10.1126/science.1071697. No abstract available.
- Background: PubMed 11717461Wright KP Jr, Hughes RJ, Kronauer RE, Dijk DJ, Czeisler CA; New Collective Author. Intrinsic near-24-h pacemaker period determines limits of circadian entrainment to a weak synchronizer in humans. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):14027-32. doi: 10.1073/pnas.201530198.
- Background: PubMed 10930561Wright KP Jr, Myers BL, Plenzler SC, Drake CL, Badia P; New Collective Author. Acute effects of bright light and caffeine on nighttime melatonin and temperature levels in women taking and not taking oral contraceptives. Brain Res. 2000 Aug 11;873(2):310-7. doi: 10.1016/s0006-8993(00)02557-9.
- Background: PubMed 9042530Wright KP Jr, Badia P, Myers BL, Plenzler SC, Hakel M. Caffeine and light effects on nighttime melatonin and temperature levels in sleep-deprived humans. Brain Res. 1997 Jan 30;747(1):78-84. doi: 10.1016/s0006-8993(96)01268-1.
- Click here for the University of Colorado at Boulder Sleep and Chronobiology Laboratory web siteLink provided by the sponsor.
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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.
Kenneth P. Wright, PhD principal investigator
University of Colorado at Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin, Methylxanthine and Light Therapy in people with Sleep Disorders, Circadian Rhythm, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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 17 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: status not confirmed, as of the sponsor's last update on 25 Aug 2009. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gayle Wright, MS (303-735-1923, Sleep.Study@colorado.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit) (time frame: 24 hour). 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 NCT00387179, which also lists 8 linked publications.
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 25 Aug 2009.