An interventional study of Therapy light room and Standard light in Sleep Fragmentation, Behavioural and Psychiatric Symptoms of Dementia and Dementia, sponsored by University of Bergen. Completed at 1 site in Norway. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-05-07.
Sponsored by University of Bergen · Not applicable, Interventional, and Treatment
This intervention study will investigate the effect of therapy light rooms on sleep, circadian rhythms, mood, behavioural problems and function in nursing home (NH) patients with dementia.
People with dementia often have fragmented night-time sleep, prolonged night-time awakenings and increased daytime sleep. Behavioural and psychological symptoms of dementia (BPSD) (e.g. agitation, depression) are also common. Noticeably, both sleep problems and BPSD are related to a disturbed circadian rhythm. Light is the most important input to the circadian system, and exposure to sufficient daylight is important for entrainment of the circadian rhythm to the surroundings. Dementia patients living in nursing homes (NH) are less exposed to daylight than dementia patients living at home. Bright light therapy is a promising treatment in these patients as it may improve sleep, BPSD, and independent functioning. However, traditional bright light treatment has not been routinely employed in NH patients or patients with dementia. This may be related to difficulties in achieving adherence to the traditional treatment and thus the benefit of bright light therapy for people with dementia still remains unclear.
DEM.LIGHT uses modern LED (light-emitting diodes) technology that enables light therapy with the least possible interference of the day-to-day life in NHs, as the treatment is not confined to a light source presupposing behavioural compliance. Ceiling-mounted LED-sources can be programmed in terms of timing, light intensity and colour temperature. DEM.LIGHT uses this to provide therapy light rooms with a dynamic light condition that better emulates natural light throughout the day. The study is a cluster-randomized trial evaluating the effect of therapy light rooms on various measures of physical and mental health in NH patients with dementia. Data will be collected at baseline, after 8 and 16 weeks of treatment, and at the end of the intervention period (24 weeks).
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
This study's enrollment of 70 is above the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →University of Bergen is the lead sponsor of 143 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group (4 NH units, about 35 patients) will receive light therapy administered via LED technology. The light will vary in intensity and colour temperature throughout the day. Ceiling-mounted LED-lights are installed in the living rooms of participating nursing home units. Between 07:00 and 10:00 light of 400 lux at eye level, with 4000 K, will be provided. Between 10:00 and 15:00 the light will comprise 1000 lux at eye level, with 6000 K. From 15:00 to 18:00 the light will comprise 400 lux at eye level and 4000 K. When light is on from 18:00 to 07:00, standard light (about 100 lux at eye level, 3000K) will be administered.
Other: Therapy light room
This group (4 NH units, about 35 patients) will receive "standard light" (100 lux at eye level, 3000K). The light will be administered between 07:00 and 18:00; and the same when light is on between 18:00 to 07:00. This represents the placebo light intervention, which at the same time ensures a constant standard light condition in all control units.
Other: Standard light
See group description
See group description
Change in actigraphy recorded sleep and circadian rhythm
An actigraph (Actiwatch 2, Philips Respironics) is worn for 7 consecutive days
Time frame: Baseline and week 8, 16, and 24
Change in proxy-rated sleep
Sleep Disorders Inventory (a proxy-rated instrument) is completed. A total score is calculated from the product of the average frequency and average severity of seven symptoms. The total score ranges from 0 (best) to 12 (worst).
Time frame: Baseline and week 8, 16, and 24
Change in circadian rhythm of core body temperature
A swallowed capsule (e-Celsius, BodyCap) records core body temperature for 24 hours.
Time frame: Baseline and week 8, 16, and 24
Change in the Neuropsychiatric Inventory - Nursing Home version (NPI-NH)
NPI-NH is a proxy-rated instrument to assess neuropsychiatric disturbances in people with dementia. A total score is calculated from the product of the frequency and severity of 12 items. The total score ranges from 0 (best) to 144 (worst).
Time frame: Baseline and week 8, 16 and 24
Change in the Cohen-Mansfield Agitation Inventory (CMAI)
CMAI is a proxy-rated instrument measuring agitation symptoms. The instrument has 29 items, and the total score ranges from 29 (best) to 203 (worst).
Time frame: Baseline and week 8, 16 and 24
Change in the Cornell Scale of Depression in Dementia (CSDD)
CSDD is a proxy-rated instrument addressing depression in people with dementia. The instrument has 19 items, and the total score ranges from 0 (best) to 38 (worst).
Time frame: Baseline and week 8, 16 and 24
Change in the Quality of Life in Late-Stage Dementia (QUALID)
QUALID is a proxy-rated instrument validated for use in people with dementia. 11 behaviours are rated on a 5-point Likert scale, and the total score ranges from 11 (best) to 55 (worst).
Time frame: Baseline and week 8, 16 and 24
Change in the Mobilization-Observation-Behaviour-Intensity-Dementia 2 (MOBID-2)
MOBID-2 is a proxy-rated instrument to assess pain in people with dementia. The instrument consists of two parts, each with five items. In part 1, pain intensity is inferred by the patient's pain behaviours during standardized, guided movements. In part 2, pain intensity is assessed by the patient's pain behaviours related to internal organs, head, and skin. A total score, ranging from 0-10, is set based on an overall assessment of the pain intensity scores in part 1 and 2.
Time frame: Baseline and week 16 and 24
Change in the Mini Mental State Examination (MMSE)
MMSE is a cognitive function screening instrument, which discerns severity of cognitive impairment on a 30 point scale. Lower scores represent severe impairment.
Time frame: Baseline and week 24
Change in the Functional Assessment Staging (FAST)
FAST is a proxy-rated instrument validated for use in people with dementia. It ascertains the severity of dementia in seven stages of functioning.
Time frame: Baseline and week 8, 16 and 24.
Change in the Physical Self-Maintenance Scale
Physical Self-Maintenance Scale assesses Activities of Daily living (ADL) pertaining to physical function. The scale consists of six items, and the total score ranges from 0 to 30. Lower values indicate better functioning.
Time frame: Baseline and week 8, 16 and 24
Clinical Global Impression of Change (CGIC)
Rates globally perceived improvement ranging from very much worse (0) to very much improved (6). From baseline to week 8, 16 and 24.
Time frame: Week 8, 16 and 24
Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)
RUD-FOCA is a cost-analysis of time invested in care during 24 hours
Time frame: Baseline and week 8, 16 and 24
Change in general health
The medical journal will be used to register change in total use of medication, blood pressure, pulse, weight and diagnoses.
Time frame: Baseline and week 8, 16 and 24
Change in burden of care
The NPI-NH total disruptiveness score is calculated by adding the occupational disruptiveness scores for the 12 items of the NPI-NH (each scored 0-5). The total disruptiveness score has a range of 0-60, with higher values representing more occupational disruptiveness.
Time frame: Baseline and week 8, 16 and 24
Change in staff alertness
Karolinska Sleepiness Scale comprises a single item assessing state sleepiness on a scale from 1 (very alert) to 9 (very sleepy, fighting sleep).
Time frame: Baseline and week 8, 16 and 24
Change in staff sleep
Bergen Insomnia Scale consists of six items. Each item is scored from 0 to 7, according to the number of days per week a specific insomnia symptom has occurred during the last month. The total score ranges from 0-42.
Time frame: Baseline and week 8, 16 and 24
Change in staff fatigue
The Chalder Fatigue Questionnaire has 13 items. The first 11 items (scored 0-3) are used to calculate a total score with a range from 0-33. Higher values represent more fatigue.
Time frame: Baseline and week 8, 16 and 24
Change in staff mental health
Measured by Hospital Anxiety and Depression Scale (HADS). HADS consists of two subscales, one for anxiety and one for depression, each with 7 items. The subscale scores range from 0 to 21. Higher values represent worse mental health (anxiety/depression).
Time frame: Baseline and week 8, 16 and 24
Change in staff health related quality of life
The SF-12 health survey consists of 12 items. Two summary scores (the Mental Health Component Summary and the Physical Health Component Summary) are calculated based on an algorithm from the User's Manual for the SF-12 Health Survey.
Time frame: Baseline and week 8, 16 and 24
Ran from Sep 2017 to primary completion in Apr 2018, 6 months.
Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's 6 months is below that.
Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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