Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000616673
Ethics application status
Approved
Date submitted
6/06/2014
Date registered
10/06/2014
Date last updated
18/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of modified night lighting on sleep characteristics, and activity levels among admitted inpatients.
Scientific title
A prospective observational study among admitted inpatients evaluating the effects of a modified night lighting intervention on patient sleep characteristics, activity levels, and related environmental variables compared with patients in rooms where the modified night lighting is absent.
Secondary ID [1] 284750 0
nil
Universal Trial Number (UTN)
U1111-1157-8275
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inpatient sleep and activity levels 292118 0
Condition category
Condition code
Public Health 292451 292451 0 0
Health service research
Other 292452 292452 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study, we intend to observe the patient-level effects of a night lighting intervention being implemented as part of a separate study, a stepped wedge cluster randomised controlled trial across six wards at the Royal Brisbane and Women's Hospital (RBWH) - ANZ trial registration ID: ACTRN12614000615684. The cluster RCT examines the effect of the intervention on ward level inpatient fall rates.

The observational study described here will additionally examine the effect of the modified environment on other patient level effects, specifically sleep and activity levels.
Here, we will recruit one patient per ward per month across the 14 month period of the cluster RCT (84 patients in total to be recruited). It is anticipated that across the 14 month trial period, 42 patients will be exposed to the modified environment.

At the initial interview (baseline) we will ask participants to rate their visual impairment, hearing impairment, pre-admission sleepiness and sleep behaviour, current levels of sleepiness, sleep behaviour and insomnia, causes of current sleep disruption and current functional status.

After the initial interview, we will follow-up participants on day three, seven and twelve (+/- one day) unless discharged from hospital or transferred out of the room earlier,. We will ask patients to rate current levels of sleepiness, sleep behaviour and insomnia, current functional status, and causes of sleep disruption over preceding days. We will also ask participants to rate their satisfaction with the physical environment and suggestions for improvements in the physical environment to support patient sleep and mobility.

In addition to the above measures, we will collect continuous data on patient activity levels and light exposure through the use of a wrist worn actigraph (maximum of 12 days from initial interview). Over the same period, we will collect continuous data on environmental light variation in the room and bathroom through the use of a wall-mounted light sensing data logger. Opening and closing of the toilet door will be collected using a simple state change data logger.
Intervention code [1] 289540 0
Not applicable
Comparator / control treatment
It is anticipated by randomly selecting 6 patients per ward per month over the 14 month trial period, we will have recruited 42 patients who have been exposed to an unaltered physical environment (as a consequence of the cluster RCT stepped wedge study design). These 42 patients will be the comparison group for the present observational study.
Control group
Active

Outcomes
Primary outcome [1] 292315 0
Day-time sleepiness

This will be measured using the Karolinska Sleepiness Scale (KSS) [1] is a short 9-item self-report questionnaire that is a measure of a situational sleepiness. The KSS is sensitive to daily changes in levels of sleepiness [2].

[1] Kecklund, G., & Akerstedt, T. (1992). The psychometric properties of the Karolinska Sleep Questionnaire. J Sleep Res, 1(Suppl 1), 113.

[2] Kaida M, Takahashi T, Akerstedt A, Nakata Y, Otsuka T, Haratani K, et al. (2006). Validation of the Karolinska sleepiness scale against performance and EEG variables. Clinical Neurophysiology, 117, 1574–81.
Timepoint [1] 292315 0
Days 0, 3, 7 and 12 (initial interview and maximum of three follow up points) unless patient is discharged or moved to another room prior to day 12.
Primary outcome [2] 292316 0
Insomnia

Insomnia is the most likely manifestation of sleep disturbance and therefore is an important construct to measure. We will measure this using the Insomnia Severity Index (ISI) which is a brief validated seven-item self-report measure of the individual’s subjective perception of insomnia (sleep onset, maintenance and early and unintended waking) as well as amount of concern generated due to those symptoms [1]. This ISI has been previously utilised in prevalence studies on insomnia in hospitalised older populations [2].

[1] Bastien, C. H., Vallieres, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep medicine,2(4), 297-307.

[2] Stone, K. L., Ensrud, K. E., & Ancoli-Israel, S. (2008). Sleep, insomnia and falls in elderly patients. Sleep medicine, 9, S18-S22.
Timepoint [2] 292316 0
Days 0, 3, 7 and 12 (initial interview and maximum of three follow up points) unless patient is discharged or moved to another room prior to day 12.
Primary outcome [3] 292317 0
Sleep and Activity levels

In order to collect objective data on participant sleep quality, sleep fragmentation, total sleep, and overall activity levels, we will use wrist worn actigraphy measurement. Actigraphs are wearable sensors that allow logging of movement data and have been extensive used in clinical research over the past 20 years. Actigraphy data has been validated against gold-standard polysomnography methods and offers a reliable tool for measuring sleep outside of a sleep laboratory environment [1] We will be using a Philips Actiwatch 2 which is a small, rugged, water-proof wrist worn data logger with long battery life and will provide us with a measure of rest-activity patterns and sleep. The inbuilt light sensor will allow us to also measure dosage of ambient white light over a 24-hour period. The Philips Actiwatch range has been applied in over 30 clinical trials to date including the study of
sleep wake patterns in older acute patients [2, 3].


1. Ancoli-Israel, S., Cole, R., Alessi, C., Chambers, M., Moorcroft, W., & Pollak, C. (2003). The role of actigraphy in the study of sleep and circadian rhythms. American Academy of Sleep Medicine Review Paper. Sleep, 26(3), 342-392.

2. Yoder, J. C., Staisiunas, P. G., Meltzer, D. O., Knutson, K. L., & Arora, V. M. (2012). Noise and sleep among adult medical inpatients: far from a quiet night. Archives of internal medicine, 172(1), 68-70.

3. Vinzio, Stephane, et al. "Actigraphic assessment of the circadian rest–activity rhythm in elderly patients hospitalized in an acute care unit." Psychiatry and clinical neurosciences 57.1 (2003): 53-58.
Timepoint [3] 292317 0
Continuous measurement commenced at initial interview and continued for a maximum of 12 days or until patient is discharged or moved to another room (whichever occurs earlier).
Secondary outcome [1] 308704 0
Overnight maximum lighting levels and variation in patient room and toilet.

As the modified lighting will be installed both inside the patient room and ensuite toilet, we will monitor variations in overnight lighting levels using a HOBO Lighting Variance Meter (Onsetcomp HOBO U12-012) mounted on the wall in the patient room and toilet. The HOBO U12-012 data logger is a high frequency, high-resolution device capable of a measuring range between 1 and 3000 lumens/square foot. This data logger has been used in clinical sleep environment illumination studies previously. As the Actiwatch sensor will be the primary measure of participant white light dosage, we will affix the data logger outside the immediate patient bedside environment (outside the area circumscribed by patient privacy curtains) in order to measure overall variation in room lighting profile. We will set the sampling rate to one measurement every 30 seconds.
Timepoint [1] 308704 0
Continuous measurement commenced at initial interview and continued for a maximum of 12 days or until patient is discharged or moved to another room (whichever occurs earlier).
Secondary outcome [2] 308705 0
Frequency with which toilet doors are opened and closed overnight.

In order to understand whether participants are exposed to the modified lighting environment within the toilet overnight, we will log the times of door opening and closing. This will be done through an unobtrusive door mounted data logger that measures contact with a magnetic latch (Onsetcomp HOBO UX90-001). The HOBO UX90-001 is a high capacity data logger appropriate to measuring simple state changes and will allow us to contextualise activity levels at night.
Timepoint [2] 308705 0
Continuous measurement commenced at initial interview and continued for a maximum of 12 days or until patient is discharged or moved to another room (whichever occurs earlier).
Secondary outcome [3] 308706 0
Self-reported causes for disruptions to sleep.

Sleep disruptions can occur due to multiple factors in addition to light levels. Therefore, we will ask patients to what degree their sleep was disrupted by specific causes (rated on a 7-point likert scale ranging from 'Never' to 'Constantly').

The specific items are: 'Pain or Discomfort', 'Anxiety and Thoughts', 'Feeling unwell', 'People talking in your room', 'Alarms and sounds from medical devices', 'Sounds made by other patients', 'Bright lights being left on overnight', 'Bright lights being switch on while you sleep', 'Staff providing care to you', 'Staff providing care to others' AND ' Volume of someone else's television'.

The current eleven items represent a refinement over a previous version developed after a review of the literature and trialled through local research.
Timepoint [3] 308706 0
Days 0, 3, 7 and 12 (initial interview and maximum of three follow up points) unless patient is discharged or moved to another room prior to day 12.
Secondary outcome [4] 308707 0
Functional status

We will measure patient functional status using the 5-item Barthel Index [1] to capture any variations in functional status as this would influence the interpretation of mobility data collected through continuous direct monitoring. The Barthel Index is a widely used, valid and accepted tool for screening and assessing independence in activities of daily living (ADL) in geriatric settings, including older hospitalised patients.

[1] Hobart, J. C., & Thompson, A. J. (2001). The five item Barthel index. Journal of Neurology, Neurosurgery & Psychiatry, 71(2), 225-230.
Timepoint [4] 308707 0
We will administer the 5-item Barthel Index (self-report method) at initial interview as well as at day 3, 7 and 12 after initial interview.
Secondary outcome [5] 308708 0
Pre-admission sleep behaviour

To evaluate whether current insomnia or sleep fragmentation is new or pre-existing we will administer the Epworth Sleepiness Scale (ESS). The ESS is a widely used and valid 8-item self-administered instrument for measuring for excessive daytime sleepiness [1]. Excessive daytime sleepiness is associated with a range of disorders and has been associated with falls in certain older groups [2].

1. Johns, M. W. (1991). A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep, 14(6), 540-545.

2. Spindler, M., Gooneratne, N. S., Siderowf, A., Duda, J. E., Cantor, C., & Dahodwala, N. (2013). Daytime sleepiness is associated with falls in Parkinson's disease. Journal of Parkinson's disease, 3(3), 387-391
Timepoint [5] 308708 0
Once at initial interview.
Secondary outcome [6] 308709 0
Impairment of vision

As participant visual status would influence the benefit derived from an environmental lighting solution we will ask participants to self-rate the functional impact of any visual impairment using the Impact of Visual Impairment Scale (IVIS). The IVIS is a widely cited and validated brief five-item instrument [1], which measures impact of vision impairment in terms of difficulties with simple tasks. Individual IVIS items are suited to older people in the inpatient setting and measure constructs relevant to study aims.

1. Weih, L. M., Hassell, J. B., & Keeffe, J. (2002). Assessment of the impact of vision impairment. Investigative ophthalmology & visual science, 43(4), 927-935.
Timepoint [6] 308709 0
Once at initial interview.
Secondary outcome [7] 308710 0
Hearing impairment

The presence of hearing impairment is of secondary interest to contextualise data on causes of sleep disruption as patients with hearing impairment may be less affected by environmental noise than those patients with unimpaired hearing. We will measure the functional impact of hearing impairment among study participants by using the Hearing Handicap Inventory for the Elderly - Screening (HHIE- S). The HHIE-S is a short 10-item measure of the social, emotional and functional impacts of hearing impairment rather than a definitive measure of the degree of hearing impairment [1]. However, as a self-report measure, it has demonstrated excellent reliability and specificity in detecting the level of impact of hearing loss [2].

1. Gates, G. A., Murphy, M., Rees, T. S., & Fraher, A. (2003). Screening for handicapping hearing loss in the elderly. Journal of Family Practice, 52(1), 56-62.

2. Sindhusake, D., Mitchell, P., Smith, W., Golding, M., Newall, P., Hartley, D., & Rubin, G. (2001). Validation of self-reported hearing loss. The Blue Mountains hearing study. International Journal of Epidemiology, 30(6), 1371-1378.
Timepoint [7] 308710 0
Once at initial interview.

Eligibility
Key inclusion criteria
Patients admitted to one of six RBWH wards recruited to a larger cluster randomised controlled trial (registration ID: ACTRN12614000615684) studying the effect of modified night lighting on inpatient falls.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude patients who have been in the ward for longer than 30 days or are due to be discharged within the following 3 days.

We will also exclude patients that have provided data for the current study in a previous month (on any wards).

Patients with known cognitive impairment will be excluded, as an important element of this observational study is to capture data on participant subjective experience of the sleep environment, on sleep quality and on disruptions. Self-report data of this nature could be unreliable in cognitively impaired populations.

Due to lack of multi-language versions of the scales used in this study, we will also exclude patients who are not fluent in English.

Lastly, we will exclude patients who are unstable or too unwell to participate.

Patient eligibility will be established by the study research officer (SRO) in consultation with the ward nurse manager or shift coordinator at each recruitment point (a calendar month).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Sample size calculations were not undertaken due to the exploratory nature of this mixed methods observational sub-study. We believe that recruiting 14 patients per ward (84 participants in total) over the length of the trial will provide adequate saturation of all possible themes within the qualitative data. Concurrent quantitative analysis will also be exploratory in nature, and thus sample size estimation was not considered.

Data Analysis

We will employ a full-range of descriptive statistics to model the main features and distribution characteristics of the final data set. We will explore differences in patient sleep data and self-reported sleep and mobility behaviour between control and intervention environments through both qualitative and quantitative methods. Longitudinal data collected through actigraphy and environmental sensing will be subjected to supervised machine learning exploratory analysis and data mining algorithms to classify the raw outputs against specific activity and event markers. Aggregated environmental sensing data will be graphically modeled through the development of scatter plots and histograms for visual identification of patterns and differences between data pertaining to the intervention and control environments.

Categorical data on causes of sleep disruptions collected through patient interview will additionally be subjected to content and thematic analysis. Concurrently, we will undertake multi-level mixed effect generalised linear modeling with the quantitative data, using a Gaussian family and identity link for normally distributed continuous data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/06/2014
Actual
12/06/2014
Date of last participant enrolment
Anticipated
30/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2606 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 8279 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 289368 0
Other Collaborative groups
Name [1] 289368 0
Australian Centre for Health Services Innovation
Country [1] 289368 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Royal Brisbane and Women's Hospital
Cnr of Butterfield Street and Bowen Bridge Road
Herston
Queensland 4029
Country
Australia
Secondary sponsor category [1] 288053 0
None
Name [1] 288053 0
Address [1] 288053 0
Country [1] 288053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291134 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 291134 0
Ethics committee country [1] 291134 0
Australia
Date submitted for ethics approval [1] 291134 0
Approval date [1] 291134 0
14/02/2014
Ethics approval number [1] 291134 0
HREC/13/QRBW/450

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

Contacts
Principal investigator
Name 49026 0
Mr Satyan Chari
Address 49026 0
Safety and Quality Unit
Level 7 Block 7
Royal Brisbane and Women's Hospital
Metro North Hospital and Health Service
Herston Queensland 4029
Country 49026 0
Australia
Phone 49026 0
61 7 3646 5375
Fax 49026 0
61 7 3646 1406
Email 49026 0
[email protected]
Contact person for public queries
Name 49027 0
Satyan Chari
Address 49027 0
Safety and Quality Unit
Level 7 Block 7
Royal Brisbane and Women's Hospital
Metro North Hospital and Health Service
Herston Queensland 4029
Country 49027 0
Australia
Phone 49027 0
61 7 3646 5375
Fax 49027 0
61 7 3646 1406
Email 49027 0
[email protected]
Contact person for scientific queries
Name 49028 0
Satyan Chari
Address 49028 0
Safety and Quality Unit Level 7 Block 7
Royal Brisbane and Women's Hospital
Metro North Hospital and Health Service
Herston Queensland 4029
Country 49028 0
Australia
Phone 49028 0
61 7 3646 5375
Fax 49028 0
61 7 3646 1406
Email 49028 0
[email protected]

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