Shift-Work Sleep DisorderPhase 1SETS-noviceNCT00786266
Sleep Enhancement Training Study for Novice Shiftworkers
A Phase 1 study testing Sleep Enhancement Training System and NIOSH shiftwork booklet in people with Shift-Work Sleep Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in shiftwork-naive new nurse graduates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- Sleep Enhancement Training System and NIOSH shiftwork booklet
- 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 siteUnited States
- Study dates
- Nov 2008to May 2010
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months
Who cannot join
- > 6 months experience working night-shift
- current diagnosis of sleep disorder or affective illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in shiftwork-naive new nurse graduates.
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- Sleep Enhancement Training System, NIOSH shiftwork booklet
- Keywords
- shift-work, sleep, nurse, relaxation
- 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.
Sleep Enhancement Training SystemBehavioural
4 week program of readings and relaxation programs
NIOSH shiftwork bookletBehavioural
weekly readings about coping with shiftwork
| Study group | Role | What they receive |
|---|---|---|
| NIOSH shiftwork booklet | Active comparator | Not described Receives: Behavioral: NIOSH shiftwork booklet |
| Sleep Enhancement Training System | Experimental | Not described Receives: Behavioral: Sleep Enhancement Training System |
What is being measured
The primary outcome is the main question the study is designed to answer.
actigraphy measures of sleep
Measured: 6 weeks
Secondary outcomes (1)
subjective measures of sleep and well-being
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Christopher R Alsten, PhD, Principal investigator, Inner Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786266
- Sponsor's protocol ID
- SETS-novice
- Other IDs
- R43NR010688
- Acronym
- SETS-novice
- Status last verified
- Jun 2010
- First submitted
- 4 Nov 2008
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Enhancement Training Study for Novice Shiftworkers
- ClinicalTrials.gov ID
- NCT00786266
- Acronym / sponsor ID
- SETS-novice / SETS-novice
- Conditions
- Shift-Work Sleep Disorder
- Keywords
- shift-work, sleep, nurse, relaxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Nov 2008 (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.
The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in shiftwork-naive new nurse graduates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIOSH shiftwork booklet | Active comparator | Behavioral: NIOSH shiftwork booklet |
| Sleep Enhancement Training System | Experimental | Behavioral: Sleep Enhancement Training System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months
Key exclusion criteria (2 listed)
- > 6 months experience working night-shift
- current diagnosis of sleep disorder or affective illness
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 Enhancement Training System4 week program of readings and relaxation programs | Behavioural | Sleep Enhancement Training System |
| NIOSH shiftwork bookletweekly readings about coping with shiftwork | Behavioural | NIOSH shiftwork booklet |
Primary outcome
actigraphy measures of sleep
Time frame: 6 weeks
1 secondary outcome
subjective measures of sleep and well-being
Time frame: 6 weeks
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 23 Jun 2010.
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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.
Christopher R Alsten, PhD principal investigator
Inner Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sleep Enhancement Training System and NIOSH shiftwork booklet in people with Shift-Work Sleep Disorder, run by University of California, San Francisco 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 2 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 23 Jun 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
actigraphy measures of sleep (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2010.