Shift-Work Sleep DisorderNCT00900159
Effects of Daytime Eszopiclone Administration in Shift Workers
A study testing eszopiclone in people with Shift-Work Sleep Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- eszopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-50 (men or women)
- Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)
- A willingness and ability to comply with study procedures
- If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device [IUD]).
Who cannot join
- Current diagnosis of DSM-IV Axis I disorder (other than insomnia)
- Regular treatment (>1time/wk) with CNS-active medication within 1 month of first inpatient visit
- Uncontrolled medical illness that would interfere with participation in the study
- BMI>32 or < 19.8 kg/m2
- Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD
- Periodic Leg Movement of Sleep Index (PLMSi)>20/hr of sleep or Respiratory Desaturation Index (RDI)>15 on polysomnography (PSG)
Show all 11Show fewer
- Current alcohol or drug dependence/abuse
- Menopausal or peri-menopausal symptoms that disrupt sleep
- Pregnant, lactating, or planning to become pregnant
- Current smoking of more than 10 cigarettes per day
- Current use of over the counter sleep aids such as Benadryl or melatonin
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift
The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.
Read the detailed description
The current study seeks to extend the currently available treatments for SWSD by addressing the putative root cause of the problem-the inability of night-shift workers with or without SWSD- to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. Even healthy, young subjects who are sleep-deprived overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of REM sleep. Many night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep. Pharmacological interventions to decrease awakenings and improve total sleep time during daytime sleep could improve subsequent alertness during a night shift. Improving the wakefulness of night-shift workers over the nighttime could result in substantial benefits for the individual workers, improve workplace productivity and safety, and improve public health.
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- eszopiclone, matching placebo
- Keywords
- Shift-work, SWSD, eszopiclone, MWT, shiftworkers
- 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.
eszopicloneDrug
Also called Lunesta
3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
matching placeboDrug
Also called placebo
matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
| Study group | Role | What they receive |
|---|---|---|
| eszopiclone | Experimental | Treatment with eszopiclone Receives: Drug: eszopiclone |
| matching placebo | Placebo comparator | Treatment with matching placebo Receives: Drug: eszopiclone; Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests
Participants underwent four Maintenance of Wakefulness Tests (MWT) at 2-hour intervals during the simulated night shift starting 5 hours after wake time. MWT range from 0 to 40 minutes, where shorter times to fall asleep represent greater sleepiness (worse). MWT tests are averaged, for a mean in minutes.
Measured: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Secondary outcomes (4)
EEG-recorded Sleep Efficiency
Polysomnographic recordings of daytime sleep were made at sleep screen (8.5hr) and during daytime sleep episodes of 8.5 hours of duration during treatment visits. Sleep efficiency is calculated based on the time the participant spent in bed and the actual time the participant slept.
Measured: On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Subjective Sleepiness and Performance
The Karolinska Sleepiness Scale (KSS), a nine point Visual Analog Scale of alertness/sleepiness, was used to assess subjective sleepiness. The KSS is a scale from 1 to 9, from minimum to maximum sleepiness.
Measured: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Objective Vigilance Task Performance
A computer-based Flanker Task elicits responses to an incongruent pairing of stimuli measured as reaction time, in milliseconds. The Flanker task tests response inhibition, or the participants suppression of an unwanted response. A target stimulus (symbol) is "flanked" by non-target stimuli (symbols) that are the same as the target stimulus, opposite of the target stimulus, or neutral with respect to the target stimulus. The task is intended to assess the ability to maintain "selective attention" in the presence of distractors.
Measured: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Sleep-dependent Memory Consolidation
A computer-based Word-pair tasks is the number of words recalled after sleep from a list of words shown prior to going to sleep.
Measured: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc., Massachusetts General Hospital
- Responsible party
- Principal investigator, Orfeu M. Buxton, Brigham and Women's Hospital
- Investigators
- Orfeu M Buxton, Ph.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900159
- Sponsor's protocol ID
- ESRC-977
- Other IDs
- 2009-P-000019
- Status last verified
- Jul 2017
- First submitted
- 13 Apr 2009
- Last updated
- 30 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: After publication of initial results, would require institutional data sharing agreement with Partners Inc (Brigham and Women's Hospital), and Dr. Buxton
Publications
Marino M, Li Y, Pencina MJ, D'Agostino RB Sr, Berkman LF, Buxton OM. Quantifying cardiometabolic risk using modifiable non-self-reported risk factors. Am J Prev Med. 2014 Aug;47(2):131-40. doi: 10.1016/j.amepre.2014.03.006. Epub 2014 Jun 17.
PubMed 24951039
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift
- ClinicalTrials.gov ID
- NCT00900159
- Acronym / sponsor ID
- ESRC-977
- Conditions
- Shift-Work Sleep Disorder
- Keywords
- Shift-work, SWSD, eszopiclone, MWT, shiftworkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc., Massachusetts General Hospital
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 30 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.
Detailed description
The current study seeks to extend the currently available treatments for SWSD by addressing the putative root cause of the problem-the inability of night-shift workers with or without SWSD- to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. Even healthy, young subjects who are sleep-deprived overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of REM sleep. Many night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep. Pharmacological interventions to decrease awakenings and improve total sleep time during daytime sleep could improve subsequent alertness during a night shift. Improving the wakefulness of night-shift workers over the nighttime could result in substantial benefits for the individual workers, improve workplace productivity and safety, and improve public health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eszopiclone | Experimental | Drug: eszopicloneTreatment with eszopiclone |
| matching placebo | Placebo comparator | Drug: eszopiclone, Drug: matching placeboTreatment with matching placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-50 (men or women)
- Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)
- A willingness and ability to comply with study procedures
- If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device [IUD]).
Key exclusion criteria (11 listed)
- Current diagnosis of DSM-IV Axis I disorder (other than insomnia)
- Regular treatment (>1time/wk) with CNS-active medication within 1 month of first inpatient visit
- Uncontrolled medical illness that would interfere with participation in the study
- BMI>32 or < 19.8 kg/m2
- Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD
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 |
|---|---|---|
| eszopicloneAlso: Lunesta3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) | Drug | eszopiclone, matching placebo |
| matching placeboAlso: placebomatching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab) | Drug | matching placebo |
Primary outcome
Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests
Time frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Participants underwent four Maintenance of Wakefulness Tests (MWT) at 2-hour intervals during the simulated night shift starting 5 hours after wake time. MWT range from 0 to 40 minutes, where shorter times to fall asleep represent greater sleepiness (worse). MWT tests are averaged, for a mean in minutes.
4 secondary outcomes
EEG-recorded Sleep Efficiency
Time frame: On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Subjective Sleepiness and Performance
Time frame: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Objective Vigilance Task Performance
Time frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Sleep-dependent Memory Consolidation
Time frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24951039Marino M, Li Y, Pencina MJ, D'Agostino RB Sr, Berkman LF, Buxton OM. Quantifying cardiometabolic risk using modifiable non-self-reported risk factors. Am J Prev Med. 2014 Aug;47(2):131-40. doi: 10.1016/j.amepre.2014.03.006. Epub 2014 Jun 17.
- Individual participant dataSharing planned: Undecided. After publication of initial results, would require institutional data sharing agreement with Partners Inc (Brigham and Women's Hospital), and Dr. Buxton
Related trials for Shift-Work Sleep Disorder
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Recruiting
Role of Sleep Reactivity in Shift Work Disorder
Shift-work Disorder
Not yet recruitingObservational study
Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses
Sleep, Fatigue
RecruitingPhase 4
Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance
Shift Work Schedule, Circadian Rhythm
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.
Orfeu M Buxton, Ph.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eszopiclone in people with Shift-Work Sleep Disorder, run by Brigham and Women's Hospital 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 4 inclusion and 11 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 30 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests (time frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts). 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 NCT00900159, 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 30 Aug 2017.