Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001857291
Ethics application status
Approved
Date submitted
4/11/2018
Date registered
14/11/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a scheduled nap during the night shift on sleepiness and cognition in hospital nurses
Scientific title
The effects of a scheduled nap during the night shift on sleepiness and cognitive functioning in female hospital nurses
Secondary ID [1] 296507 0
Nil known
Universal Trial Number (UTN)
U1111-1223-1977
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleepiness 310284 0
Cognitive performance decline 310285 0
Neurological 310404 0
Condition category
Condition code
Public Health 309022 309022 0 0
Health service research
Neurological 309119 309119 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleepiness and cognitive performance were compared with and without a 30-minute nap scheduled at 4:00 a.m. during the 8-hour night shift (23:00-07:00). All participants were tested on two nights with and two nights without a nap. Maximum two consecutive nights were allowed, all participants completed 4 study nights within 2 weeks period. To minimize the effect of order, participants were randomly assigned to five order groups: (1) nap/no-nap/nap/no-nap, (2) no-nap/nap/no-nap/nap, (3) nap/no-nap/no-nap/nap, (4) no-nap/nap/nap/no-nap, and (5) no-nap/no-nap/nap/nap. During the night shifts, participants reported hourly on sleepiness and performed two cognitive tests, the Letter Cancellation Task (LCT) and the Digit Symbol Substitution Task (DSST), at 3:00 and 7:00 a.m. On nights with a scheduled nap, participants were instructed to retire to a dark and quiet room for 40 minutes at 4:00 a.m. (corresponding to the nadir of circadian alertness, Borbély, 1982), to allow for an approximately 30-minute nap and an additional 10 minutes both to settle down before and to recover after the nap. On no-nap nights they continued their work as usual. To monitor sleep duration and time awake since last sleep, participants wore an actigraph 24 hours before and during the night shift. At the end of each night shift, workload, unusual events (if any occurred), and number of caffeinated beverages consumed were recorded and perceptual nap efficiency was assessed. Participants completed a sociodemographic questionnaire, the Munich ChronoType Questionnaire for Shiftwork (MCTQShift), Pittsburgh Sleep Quality Index (PSQI), and Pre-Sleep Arousal Scale (PSAS) between shifts. Study research assistants were on site to ensure adherence to the nap protocol and completion of the performance tests and study questionnaires.
Intervention code [1] 312821 0
Behaviour
Comparator / control treatment
The participants act as their own control on no-nap nights.
Control group
Active

Outcomes
Primary outcome [1] 307980 0
Levels of sleepiness measured by Karolinska Sleepiness Scale after the nap scheduled at 4 am in comparison to no-nap condition
Timepoint [1] 307980 0
At 5 am, 6 am and 7 am.
Primary outcome [2] 307981 0
The magnitude of change score of number of correct answers on Digit Symbol Substitution Task (DSST) before and after the nap (Delta 3-7) in nap compared to no-nap condition
Timepoint [2] 307981 0
DSST was performed at 3 am (before the nap) and at 7 am (after the nap)
Primary outcome [3] 307983 0
The magnitude of change score of Letter Cancellation Task (LCT) capacity and omission errors before and after the nap (Delta 3-7) in nap compared to no-nap condition
Timepoint [3] 307983 0
LCT was performed at 3 am (before the nap) and at 7 am (after the nap)
Secondary outcome [1] 353562 0
Nil
Timepoint [1] 353562 0
Nil

Eligibility
Key inclusion criteria
Working at least 75% of full time (28 hours per week) and at least one night shift per week.
Minimum age
20 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, a diagnosed sleep disorder, or chronic medical conditions that may affect sleep and/or function

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A one-way ANOVA was performed to compare sleep (SMIN, TA, NAP) and control variables (workload, unusual events, and caffeine consumption) by study nights. DSST and LCT performance between 3:00 a.m. and 7:00 a.m. sessions and between two nap/no-nap night shifts was compared using paired-sample t-tests. Differences in DSST correct responses, LCT capacity, and LCT omission errors between 3:00 a.m. and 7:00 a.m. on nap and no-nap conditions were examined via mixed-model analyses controlling for caffeine consumption, workload, and unusual events. Repeated measures analysis of variance (RM-ANOVA) was used to assess sleepiness throughout the night shift and to compare sleepiness after the nap (at 5:00, 6:00, and 7:00 a.m.) in nap and no-nap conditions. Mixed-model analyses, controlling for age, workload, unusual events, and caffeine consumption, tested the contributions of a nap, biopsychosocial factors, and Nap × Biopsychosocial interactions to sleepiness, DSST, and LCT performance measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/08/2011
Date of last participant enrolment
Anticipated
Actual
1/04/2014
Date of last data collection
Anticipated
Actual
30/04/2014
Sample size
Target
126
Accrual to date
Final
119
Recruitment outside Australia
Country [1] 20987 0
Israel
State/province [1] 20987 0

Funding & Sponsors
Funding source category [1] 301096 0
Government body
Name [1] 301096 0
Israel Ministry of Economy and Industry
Country [1] 301096 0
Israel
Primary sponsor type
University
Name
University of Haifa
Address
199 Aba Khoushy Ave, Mount Carmel, Haifa
Zip code: 3498838
Country
Israel
Secondary sponsor category [1] 300704 0
None
Name [1] 300704 0
Address [1] 300704 0
Country [1] 300704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301847 0
Western Galilee Medical Center IRB
Ethics committee address [1] 301847 0
Ethics committee country [1] 301847 0
Israel
Date submitted for ethics approval [1] 301847 0
Approval date [1] 301847 0
31/07/2013
Ethics approval number [1] 301847 0
0056–13 NHR

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88306 0
Prof Tamar Shochat
Address 88306 0
University of Haifa 199 Aba Khoushy Ave. Mount Carmel, Haifa Israel Zip code: 3498838
Country 88306 0
Israel
Phone 88306 0
+97248288010
Fax 88306 0
Email 88306 0
[email protected]
Contact person for public queries
Name 88307 0
Nataly Zion
Address 88307 0
University of Haifa 199 Aba Khoushy Ave. Mount Carmel, Haifa Israel Zip code: 3498838
Country 88307 0
Israel
Phone 88307 0
+972459988504
Fax 88307 0
Email 88307 0
[email protected]
Contact person for scientific queries
Name 88308 0
Tamar Shochat
Address 88308 0
University of Haifa 199 Aba Khoushy Ave. Mount Carmel, Haifa Israel Zip code: 3498838
Country 88308 0
Israel
Phone 88308 0
+97248288010
Fax 88308 0
Email 88308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Per the IRB's at Bnei Zion Medical Center and Western Galilee Medical Center, data is not to be shared with third parties. However, should a third party be interested, we will consult with IRB.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.