Sleep FragmentationDEMLIGHTNCT03357328
Therapy Light Rooms for Improved Sleep in Dementia Patients
A study testing Therapy light room and Standard light in people with Sleep Fragmentation and Behavioural and Psychiatric Symptoms of Dementia, run by University of Bergen at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep Fragmentation, Behavioural and Psychiatric Symptoms of Dementia, Dementia
- What is being tested?
- Therapy light room and Standard light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 25 Sep 2017to 24 Apr 2018
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years or more of age and in long term care (longer than 4 weeks)
- have dementia in accordance with DSM-V
- have either sleep/circadian rhythm disturbances, BPSD as identified by NPI-NH, or severely reduced ADL function
- provide written informed consent if the participant has capacity, if not, a written proxy informed consent from a legally authorized representative
Who cannot join
- are blind or may otherwise not benefit from light
- partake in another trial
- have a condition contra-indicated to the intervention
- have an advanced, severe medical disease/disorder and/or expected survival of less than 6 months or other aspects that could interfere with participation
- are psychotic or have a severe mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapy Light Rooms for Nursing Home Patients With Dementia - Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems (DEM.LIGHT)
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.
Read the detailed description
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).
- Being tested
- Therapy light room, Standard light
- Keywords
- Phototherapy, Nursing home, Light therapy
- Medical subject headings
- Sleep Deprivation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy light roomOther
See group description
Standard lightOther
See group description
| Study group | Role | What they receive |
|---|---|---|
| Therapy light room | Active comparator | 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. Receives: Other: Therapy light room |
| Standard light | Placebo comparator | 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. Receives: Other: Standard light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in actigraphy recorded sleep and circadian rhythm
An actigraph (Actiwatch 2, Philips Respironics) is worn for 7 consecutive days
Measured: 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).
Measured: 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.
Measured: Baseline and week 8, 16, and 24
Secondary outcomes (17)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and week 8, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start25 Sep 2017
- Primary completion21 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep FragmentationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- 4 nursing home units will receive the intervention (ceiling mounted LED-light in the living room) and 4 will receive the control condition ("standard light"). The trial lasts for 24 weeks. Data will be collected at baseline and after 8, 16 and 24 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Flo, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357328
- Sponsor's protocol ID
- UBergenDEM.LIGHT
- Other IDs
- 2016/2246
- Acronym
- DEMLIGHT
- Status last verified
- May 2018
- First submitted
- 14 Nov 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kolberg E, Hjetland GJ, Thun E, Pallesen S, Nordhus IH, Husebo BS, Flo-Groeneboom E. The effects of bright light treatment on affective symptoms in people with dementia: a 24-week cluster randomized controlled trial. BMC Psychiatry. 2021 Jul 28;21(1):377. doi: 10.1186/s12888-021-03376-y.
PubMed 34320937Hjetland GJ, Kolberg E, Pallesen S, Thun E, Nordhus IH, Bjorvatn B, Flo-Groeneboom E. Ambient bright light treatment improved proxy-rated sleep but not sleep measured by actigraphy in nursing home patients with dementia: a placebo-controlled randomised trial. BMC Geriatr. 2021 May 17;21(1):312. doi: 10.1186/s12877-021-02236-4.
PubMed 34001024Hjetland GJ, Nordhus IH, Pallesen S, Cummings J, Tractenberg RE, Thun E, Kolberg E, Flo E. An Actigraphy-Based Validation Study of the Sleep Disorder Inventory in the Nursing Home. Front Psychiatry. 2020 Mar 13;11:173. doi: 10.3389/fpsyt.2020.00173. eCollection 2020.
PubMed 32231600
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Light Rooms for Nursing Home Patients With Dementia - Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems (DEM.LIGHT)
- ClinicalTrials.gov ID
- NCT03357328
- Acronym / sponsor ID
- DEMLIGHT / UBergenDEM.LIGHT
- Keywords
- Phototherapy, Nursing home, Light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 21 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 29 Nov 2017 (actual)
- 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.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 4 nursing home units will receive the intervention (ceiling mounted LED-light in the living room) and 4 will receive the control condition ("standard light"). The trial lasts for 24 weeks. Data will be collected at baseline and after 8, 16 and 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Therapy light room | Active comparator | Other: Therapy light roomThis 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. |
| Standard light | Placebo comparator | Other: Standard lightThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years or more of age and in long term care (longer than 4 weeks)
- have dementia in accordance with DSM-V
- have either sleep/circadian rhythm disturbances, BPSD as identified by NPI-NH, or severely reduced ADL function
- provide written informed consent if the participant has capacity, if not, a written proxy informed consent from a legally authorized representative
Key exclusion criteria (5 listed)
- are blind or may otherwise not benefit from light
- partake in another trial
- have a condition contra-indicated to the intervention
- have an advanced, severe medical disease/disorder and/or expected survival of less than 6 months or other aspects that could interfere with participation
- are psychotic or have a severe mental disorder
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 |
|---|---|---|
| Therapy light roomSee group description | Other | Therapy light room |
| Standard lightSee group description | Other | Standard light |
Primary outcome
Change in actigraphy recorded sleep and circadian rhythm
Time frame: Baseline and week 8, 16, and 24
An actigraph (Actiwatch 2, Philips Respironics) is worn for 7 consecutive days
Change in proxy-rated sleep
Time frame: Baseline and week 8, 16, and 24
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).
Change in circadian rhythm of core body temperature
Time frame: Baseline and week 8, 16, and 24
A swallowed capsule (e-Celsius, BodyCap) records core body temperature for 24 hours.
17 secondary outcomes
Change in the Neuropsychiatric Inventory - Nursing Home version (NPI-NH)
Time frame: Baseline and week 8, 16 and 24
Change in the Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: Baseline and week 8, 16 and 24
Change in the Cornell Scale of Depression in Dementia (CSDD)
Time frame: Baseline and week 8, 16 and 24
Change in the Quality of Life in Late-Stage Dementia (QUALID)
Time frame: Baseline and week 8, 16 and 24
Change in the Mobilization-Observation-Behaviour-Intensity-Dementia 2 (MOBID-2)
Time frame: Baseline and week 16 and 24
Change in the Mini Mental State Examination (MMSE)
Time frame: Baseline and week 24
Change in the Functional Assessment Staging (FAST)
Time frame: Baseline and week 8, 16 and 24.
Change in the Physical Self-Maintenance Scale
Time frame: Baseline and week 8, 16 and 24
Clinical Global Impression of Change (CGIC)
Time frame: Week 8, 16 and 24
Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)
Time frame: Baseline and week 8, 16 and 24
Change in general health
Time frame: Baseline and week 8, 16 and 24
Change in burden of care
Time frame: Baseline and week 8, 16 and 24
Change in staff alertness
Time frame: Baseline and week 8, 16 and 24
Change in staff sleep
Time frame: Baseline and week 8, 16 and 24
Change in staff fatigue
Time frame: Baseline and week 8, 16 and 24
Change in staff mental health
Time frame: Baseline and week 8, 16 and 24
Change in staff health related quality of life
Time frame: Baseline and week 8, 16 and 24
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 7 May 2018.
- Derived from this study: PubMed 34320937Kolberg E, Hjetland GJ, Thun E, Pallesen S, Nordhus IH, Husebo BS, Flo-Groeneboom E. The effects of bright light treatment on affective symptoms in people with dementia: a 24-week cluster randomized controlled trial. BMC Psychiatry. 2021 Jul 28;21(1):377. doi: 10.1186/s12888-021-03376-y.
- Derived from this study: PubMed 34001024Hjetland GJ, Kolberg E, Pallesen S, Thun E, Nordhus IH, Bjorvatn B, Flo-Groeneboom E. Ambient bright light treatment improved proxy-rated sleep but not sleep measured by actigraphy in nursing home patients with dementia: a placebo-controlled randomised trial. BMC Geriatr. 2021 May 17;21(1):312. doi: 10.1186/s12877-021-02236-4.
- Derived from this study: PubMed 32231600Hjetland GJ, Nordhus IH, Pallesen S, Cummings J, Tractenberg RE, Thun E, Kolberg E, Flo E. An Actigraphy-Based Validation Study of the Sleep Disorder Inventory in the Nursing Home. Front Psychiatry. 2020 Mar 13;11:173. doi: 10.3389/fpsyt.2020.00173. eCollection 2020.
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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.
Elisabeth Flo, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy light room and Standard light in people with Sleep Fragmentation and Behavioural and Psychiatric Symptoms of Dementia, run by University of Bergen at 1 site in Norway.
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 5 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 7 May 2018. 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 Norway. 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?
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?
Change in actigraphy recorded sleep and circadian rhythm (time frame: Baseline and week 8, 16, and 24). The study lists 3 primary outcomes in all. 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 NCT03357328, which also lists 3 linked publications.
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 7 May 2018.