DementiaBLT-DementiaNCT04949984
Bright Light Therapy in Older Adults With Moderate to Very Severe Dementia
A study testing Bright light therapy in people with Dementia and Mood, run by Universidade da Coruña at 1 site in Spain.
Trial summary
INTRODUCTION: Bright light therapy (BLT) has demonstrated positive effects on sleep, mood, and behavioral problems in older adults with dementia. However, there is little research in people with advanced stages of dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Bright light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2018to 31 Dec 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65 years or older
- diagnosis of dementia
- a score ≥ 4 points on the Global Deterioration Scale (GDS; Reisberg et al., 1982), ranging from moderate to very severe cognitive decline.
Who cannot join
- high ocular sensitivity to light (photosensitivity)
- preexisting ocular abnormalities
- having any severe ocular disorder that did not allow them to open their eyes or that implied a very low visual acuity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bright Light Therapy in Older Adults With Moderate to Very Severe Dementia: Effects on Cognition, Mood, Behavior, and Physiological Parameters
INTRODUCTION: Bright light therapy (BLT) has demonstrated positive effects on sleep, mood, and behavioral problems in older adults with dementia. However, there is little research in people with advanced stages of dementia.
OBJECTIVES: Main objectives are to study the immediate effects, short and long-term effects of BLT in a sample of institutionalized older adults with moderate to very severe dementia. Later, to compare the potential effectiveness of bright light therapy sessions with other non-pharmacological interventions in people with dementia.
Read more
METHODS AND ANALYSIS: The study was a 2 x 2 randomized controlled trial using a two-group design (BLT vs. control) and two repeated measures (pre- vs. postintervention). In addition, the BLT group participants were assessed immediately before, after, and during each session. The BLT protocol consisted of 30-minute morning sessions of 10,000 lux, Monday through Friday, for 4 weeks.
For the statistical analysis, two-way analysis of variance (ANOVA) are used to determine the existence of differences at two points in time (pre- vs. post-). The Wilcoxon signed-rank test or the Paired t test are used to measure changes from before to after the intervention sessions.
Read the detailed description
INTRODUCTION: Dementia is one of the main causes of disability and dependence among older adults worldwide, constituting a public health priority due to its significant human and financial costs to society. Pharmacological and non-pharmacological interventions have been proposed for the management of its clinical manifestations. The nonpharmacological interventions, which include bright light therapy (BLT), are recommended by numerous guidelines as initial treatment strategies due to the absence of adverse events. BLT consists of the controlled application of certain levels of light that can be administered in several ways. There is some evidence that effective doses of light would stimulate circadian cycles, thus affecting sleep efficiency, depression, or behavioral problems in older adults with dementia, but there is little research on persons in advanced stages of dementia.
The lack of consensus on the protocol for BLT application, as well as the existence of little research on individuals in advanced stages of dementia, calls for further research to explore in-depth the immediate, short- and long-term effects of BLT in this population.
OBJECTIVES: Main objectives were: (1) to study the short- and long-term effects of bright light therapy on mood, behavior, sleep, and cognition in a sample of institutionalized older adults with moderate to very severe dementia; (2) to explore the immediate effects of bright light therapy sessions on behavior, mood and physiological parameters in a sample of institutionalized older adults with moderate to very severe dementia; and (3) to compare the effectiveness of bright light therapy sessions with other non-pharmacological interventions in people with dementia.
METHODS: This longitudinal, comparative and prospective study, is a 2 x 2 randomized controlled trial using a two-group design (BLT vs. control) and two repeated measures (pre- vs. postintervention). In addition, the BLT group participants were assessed immediately before, after, and during each session. Participants were recruited among residents of the Gerontological Complex La Milagrosa (A Coruña, Spain). The BLT protocol consisted of 30-minute morning sessions in the time slot between 10:30 and 12:00, 5 days a week (Monday to Friday), for 4 weeks (total 20 sessions). The devices used for the intervention were bright white light lamps providing an intensity of 10,000 lux. Four users participated in each session, placing two users per lamp, seated 70 cm from the lamp. All data analysis will be performed with the statistical programs SPSS- Statistical Package for the Social Sciences (version 25.0), RStudio software package (Version 1.3.1093), and JAMOVI (The jamovi project, 2020, Version 1.2).
- Being tested
- Bright light therapy
- Keywords
- bright light therapy, oxygen saturation, heart rate
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light therapyDevice
Also called BLT
BLT consisted of 30-minute morning sessions with an intensity of 10,000 lux, five days a week (Monday to Friday), for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bright light therapy | Experimental | The devices used for the intervention were bright white light lamps providing an intensity of 10,000 lux. Four users participated in each session, placing two users per lamp, seated in a comfortable chair with armrests 70 cm from the lamp. The sessions were 30 minutes/day in the time slot between 10:30 and 12:00 in the morning, 5 days a week (Monday to Friday) for 4 weeks (total 20 sessions). Two groups of participants per day were established, the first shift being from 10:30 to 11:00, and the second from 11:15 to 11:45 a.m., which means the stimulation of 8 people per day (month). During the sessions, while exposed to light, participants were watching documentaries on neutral topics (nature, Spanish and Galician culture, etc.). Receives: Device: Bright light therapy |
| Control group | No intervention | Participants were evaluated before and after the experimental group finishes the intervention program (pre- vs. postintervention) to facilitate an examination of the changes in the outcome measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age (years), including the birth date.
Measured: 4 weeks
Gender
Male or female.
Measured: 4 weeks
Educational level
Number of years of education (≤ 8, 9-17 or >17)
Measured: 4 weeks
Cognitive status- Screening
Mini-Mental State Examination (MMSE). Cognitive evaluation: a brief screening test for cognitive impairment. MMSE is a 30-point test, in which lower scores mean worse cognitive status. The cut-off point for determining the presence of cognitive impairment is normally set at 24 points.
Measured: 4 weeks
Severe cognitive status- Screening
Severe Mini-Mental State Examination (SMMSE). Cognitive evaluation: brief assessment of severe cognitive impairment in advanced stages of dementia. This test was applied only to individuals who obtained a score of 10 points or less in the MMSE. SMMSE, totals 30 points, lower scores mean worse cognitive status.
Measured: 4 weeks
Cognitive status- Level
Cambridge Cognitive Examination (CAMCOG). Cognitive evaluation: more comprehensive cognitive assessment of participants with moderate cognitive impairment (GDS = 4). This scale includes the evaluation of the following domains: orientation, language, memory, attention and calculation, praxis, abstraction, perception and executive function. CAMCOG is a 107- point scale and scores of less than 80 have been suggested as cut-off for dementia.
Measured: 4 weeks
Cognitive domains
Severe Cognitive Impairment Profile (SCIP). Cognitive evaluation: a more comprehensive cognitive assessment of participants with moderate-severe to very severe cognitive impairment (GDS = 5, 6 and 7). This scale allows obtaining a performance profile in each of the cognitive domains evaluated (comportment, attention, language, memory, motor, conceptualization, arithmetic, and visuospatial) and calculating a total score indicative of the degree of cognitive impairment: moderately severe, severe, very severe and profound. Higher scores mean higher cognitive impairment.
Measured: 4 weeks
Depression in Dementia
The Cornell Scale for Depression in Dementia (CSDD). Mood evaluation: assessment of signs and symptoms of major depression in patients with dementia focusing on the week preceding the interview. The Cornell Scale utilizes two semi-structured comprehensive interviews that elicits information from the patient and the informant. In those cases in which the patient is not able to respond due to the level of cognitive impairment, information is obtained only from the interview with the informant. Total score ranges from 0 to 38; above 10 indicate a probable major depression and above 18 indicates a definite major depression.
Measured: 4 weeks
Mood and behaviour
Neuropsychiatric Inventory Questionnaire (NPI-Q). Mood and behavior evaluation: a brief retrospective (1 month) caregiver self-administered questionnaire to assess caregiver distress and severity of 12 neuropsychiatric symptoms: delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating disturbances. For each of the symptoms the informant rates both its severity on a 3-point scale and the associated caregiver distress on a 5-point scale. The NPI-Q provides symptom severity and distress ratings for each symptom reported, and scores for total severity (0 to 36 points) and total distress (0 to 60 points) reflecting the sum of individual domain scores. Higher scores indicate higher severity and caregiver distress.
Measured: 4 weeks
Agitation
Cohen-Mansfield Agitation Inventory (CMAI). Mood and behavior evaluation: a caregiver rating questionnaire for the assessment of the frequency of manifestations of agitated behaviors. Ratings refer to the two weeks prior to its administration. The CMAI consists of 29 agitated behaviors, each rated on a 7-point frequency scale (ranging from 1-Never to 7-Several times an hour), with higher scores indicating more agitation.
Measured: 4 weeks
Anxiety
Rating for Anxiety in Dementia (RAID). Mood and behavior evaluation: a clinical rating scale to evaluate severity of anxiety including somatic symptoms and specific fears. Scoring should be based on the two weeks prior to the caregiver interview. The total score ranges from 0 to 40, with higher scores implying greater severity of anxiety disorder.
Measured: 4 weeks
Sleep-disturbed behaviours
Sleep Disorders Inventory (SDI). Sleep evaluation: this inventory is an expanded version of one item of the Neuropsychiatric Inventory (NPI). It records the frequency (ranging from 0 to 4), the severity (from 0 to 3), and the caregiver distress (from 0 to 5) with respect to eight sleep-disturbed behaviors referred to the two weeks prior to its administration. Higher SDI scores mean greater frequency and severity of sleep disturbances.
Measured: 4 weeks
Sleep-Actigraphy
Actiwatch AW4 - Actigraphy. Sleep evaluation: actigraphy is a non-invasive method of monitoring circadian rhythm. Actiwatchs are worn on the non-dominant wrist of the participants and record movements that are used to estimate sleep parameters with specialized algorithms in computer software programs. Both experimental and control group participants wore the actiwatch for 5 days before and 5 days after the intervention.
Among the parameters obtained from actigraphy records, the following were chosen for analysis in the present study: sleep latency, sleep efficiency and total sleep
Measured: 4 weeks
Disease severity in advanced stages of dementia.
Bedford Alzheimer Nursing Severity Scale (BANS-S). Functional evaluation: a nursing-staff administered questionnaire for the assessment of disease severity in advanced stages of dementia. The questionnaire comprises 7 items: dressing, sleep-wake cycle disturbances, speech, eating, ambulating, muscle rigidity and eye contact. BANS-S total score ranges from 7 to 28 and higher scores means higher dementia severity.
Measured: 4 weeks
Mood and behaviour during, preceding and immediately after the sessions
Interact scale. Mood and behavior evaluation: the Interact Scale, and its shortened version, named Interact short, were used for the evaluation of immediate effects in the experimental group. Both allow the assessment of changes in mood and behavior, the Interact scale during the sessions, and the Interact short scale in the 10 minutes immediately preceding and in the 10 minutes immediately following the session. Each of the items is evaluated on a 5-option answer scale ranging from "not al all" to "Nearly all the time". Higher scores mean a higher frequency of occurrence of each type of mood and behavior evaluated.
Measured: 4 weeks
Mean Heart rate
The baseline hemodynamic state is characterized by storing the mean of the three lowest values for thirty seconds of heart rate (HRrest; in BPM, beats per minute) with a finger pulse oximeter.
Measured: 4 weeks
Percentage of Oxygen saturation
Blood oxygen saturation (%) of the participants in the experimental group is recorded at the beginning and end of each session using a mobile finger pulse oximeter.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start8 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Carlos Millán Calenti, Universidade da Coruña
- Investigators
- José C. Millán-Calenti, Principal investigator, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949984
- Sponsor's protocol ID
- 2017/408
- Other IDs
- ED431C 2017/49, ED431F 2017/09, IN607C 2016/08, IN607C 2017/02, RYC-2015-18394
- Acronym
- BLT-Dementia
- Status last verified
- Jul 2021
- First submitted
- 18 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abraha I, Rimland JM, Trotta FM, Dell'Aquila G, Cruz-Jentoft A, Petrovic M, Gudmundsson A, Soiza R, O'Mahony D, Guaita A, Cherubini A. Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series. BMJ Open. 2017 Mar 16;7(3):e012759. doi: 10.1136/bmjopen-2016-012759.
PubMed 28302633Dyer SM, Harrison SL, Laver K, Whitehead C, Crotty M. An overview of systematic reviews of pharmacological and non-pharmacological interventions for the treatment of behavioral and psychological symptoms of dementia. Int Psychogeriatr. 2018 Mar;30(3):295-309. doi: 10.1017/S1041610217002344. Epub 2017 Nov 16.
PubMed 29143695Forbes D, Blake CM, Thiessen EJ, Peacock S, Hawranik P. Light therapy for improving cognition, activities of daily living, sleep, challenging behaviour, and psychiatric disturbances in dementia. Cochrane Database Syst Rev. 2014 Feb 26;2014(2):CD003946. doi: 10.1002/14651858.CD003946.pub4.
PubMed 24574061Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14. doi: 10.1176/appi.ajp.157.5.708.
PubMed 10784462Sloane PD, Figueiro M, Cohen L. Light as Therapy for Sleep Disorders and Depression in Older Adults. Clin Geriatr. 2008 Mar 1;16(3):25-31. No abstract available.
PubMed 24285919Steinberg M, Shao H, Zandi P, Lyketsos CG, Welsh-Bohmer KA, Norton MC, Breitner JC, Steffens DC, Tschanz JT; Cache County Investigators. Point and 5-year period prevalence of neuropsychiatric symptoms in dementia: the Cache County Study. Int J Geriatr Psychiatry. 2008 Feb;23(2):170-7. doi: 10.1002/gps.1858.
PubMed 17607801van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9.
PubMed 26606319Cibeira N, Maseda A, Lorenzo-Lopez L, Gonzalez-Abraldes I, Lopez-Lopez R, Rodriguez-Villamil JL, Millan-Calenti JC. Bright Light Therapy in Older Adults with Moderate to Very Severe Dementia: Immediate Effects on Behavior, Mood, and Physiological Parameters. Healthcare (Basel). 2021 Aug 19;9(8):1065. doi: 10.3390/healthcare9081065.
PubMed 34442202
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy in Older Adults With Moderate to Very Severe Dementia: Effects on Cognition, Mood, Behavior, and Physiological Parameters
- ClinicalTrials.gov ID
- NCT04949984
- Acronym / sponsor ID
- BLT-Dementia / 2017/408
- Keywords
- bright light therapy, oxygen saturation, heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Jul 2021 (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.
INTRODUCTION: Bright light therapy (BLT) has demonstrated positive effects on sleep, mood, and behavioral problems in older adults with dementia. However, there is little research in people with advanced stages of dementia.
OBJECTIVES: Main objectives are to study the immediate effects, short and long-term effects of BLT in a sample of institutionalized older adults with moderate to very severe dementia. Later, to compare the potential effectiveness of bright light therapy sessions with other non-pharmacological interventions in people with dementia.
METHODS AND ANALYSIS: The study was a 2 x 2 randomized controlled trial using a two-group design (BLT vs. control) and two repeated measures (pre- vs. postintervention). In addition, the BLT group participants were assessed immediately before, after, and during each session. The BLT protocol consisted of 30-minute morning sessions of 10,000 lux, Monday through Friday, for 4 weeks.
For the statistical analysis, two-way analysis of variance (ANOVA) are used to determine the existence of differences at two points in time (pre- vs. post-). The Wilcoxon signed-rank test or the Paired t test are used to measure changes from before to after the intervention sessions.
Detailed description
INTRODUCTION: Dementia is one of the main causes of disability and dependence among older adults worldwide, constituting a public health priority due to its significant human and financial costs to society. Pharmacological and non-pharmacological interventions have been proposed for the management of its clinical manifestations. The nonpharmacological interventions, which include bright light therapy (BLT), are recommended by numerous guidelines as initial treatment strategies due to the absence of adverse events. BLT consists of the controlled application of certain levels of light that can be administered in several ways. There is some evidence that effective doses of light would stimulate circadian cycles, thus affecting sleep efficiency, depression, or behavioral problems in older adults with dementia, but there is little research on persons in advanced stages of dementia.
The lack of consensus on the protocol for BLT application, as well as the existence of little research on individuals in advanced stages of dementia, calls for further research to explore in-depth the immediate, short- and long-term effects of BLT in this population.
OBJECTIVES: Main objectives were: (1) to study the short- and long-term effects of bright light therapy on mood, behavior, sleep, and cognition in a sample of institutionalized older adults with moderate to very severe dementia; (2) to explore the immediate effects of bright light therapy sessions on behavior, mood and physiological parameters in a sample of institutionalized older adults with moderate to very severe dementia; and (3) to compare the effectiveness of bright light therapy sessions with other non-pharmacological interventions in people with dementia.
METHODS: This longitudinal, comparative and prospective study, is a 2 x 2 randomized controlled trial using a two-group design (BLT vs. control) and two repeated measures (pre- vs. postintervention). In addition, the BLT group participants were assessed immediately before, after, and during each session. Participants were recruited among residents of the Gerontological Complex La Milagrosa (A Coruña, Spain). The BLT protocol consisted of 30-minute morning sessions in the time slot between 10:30 and 12:00, 5 days a week (Monday to Friday), for 4 weeks (total 20 sessions). The devices used for the intervention were bright white light lamps providing an intensity of 10,000 lux. Four users participated in each session, placing two users per lamp, seated 70 cm from the lamp. All data analysis will be performed with the statistical programs SPSS- Statistical Package for the Social Sciences (version 25.0), RStudio software package (Version 1.3.1093), and JAMOVI (The jamovi project, 2020, Version 1.2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light therapy | Experimental | Device: Bright light therapyThe devices used for the intervention were bright white light lamps providing an intensity of 10,000 lux. Four users participated in each session, placing two users per lamp, seated in a comfortable chair with armrests 70 cm from the lamp. The sessions were 30 minutes/day in the time slot between 10:30 and 12:00 in the morning, 5 days a week (Monday to Friday) for 4 weeks (total 20 sessions). Two groups of participants per day were established, the first shift being from 10:30 to 11:00, and the second from 11:15 to 11:45 a.m., which means the stimulation of 8 people per day (month). During the sessions, while exposed to light, participants were watching documentaries on neutral topics (nature, Spanish and Galician culture, etc.). |
| Control group | No intervention | –Participants were evaluated before and after the experimental group finishes the intervention program (pre- vs. postintervention) to facilitate an examination of the changes in the outcome measures. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age 65 years or older
- diagnosis of dementia
- a score ≥ 4 points on the Global Deterioration Scale (GDS; Reisberg et al., 1982), ranging from moderate to very severe cognitive decline.
Key exclusion criteria (3 listed)
- high ocular sensitivity to light (photosensitivity)
- preexisting ocular abnormalities
- having any severe ocular disorder that did not allow them to open their eyes or that implied a very low visual acuity.
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 |
|---|---|---|
| Bright light therapyAlso: BLTBLT consisted of 30-minute morning sessions with an intensity of 10,000 lux, five days a week (Monday to Friday), for 4 weeks. | Device | Bright light therapy |
Primary outcome
Age
Time frame: 4 weeks
Age (years), including the birth date.
Gender
Time frame: 4 weeks
Male or female.
Educational level
Time frame: 4 weeks
Number of years of education (≤ 8, 9-17 or >17)
Cognitive status- Screening
Time frame: 4 weeks
Mini-Mental State Examination (MMSE). Cognitive evaluation: a brief screening test for cognitive impairment. MMSE is a 30-point test, in which lower scores mean worse cognitive status. The cut-off point for determining the presence of cognitive impairment is normally set at 24 points.
Severe cognitive status- Screening
Time frame: 4 weeks
Severe Mini-Mental State Examination (SMMSE). Cognitive evaluation: brief assessment of severe cognitive impairment in advanced stages of dementia. This test was applied only to individuals who obtained a score of 10 points or less in the MMSE. SMMSE, totals 30 points, lower scores mean worse cognitive status.
Cognitive status- Level
Time frame: 4 weeks
Cambridge Cognitive Examination (CAMCOG). Cognitive evaluation: more comprehensive cognitive assessment of participants with moderate cognitive impairment (GDS = 4). This scale includes the evaluation of the following domains: orientation, language, memory, attention and calculation, praxis, abstraction, perception and executive function. CAMCOG is a 107- point scale and scores of less than 80 have been suggested as cut-off for dementia.
Cognitive domains
Time frame: 4 weeks
Severe Cognitive Impairment Profile (SCIP). Cognitive evaluation: a more comprehensive cognitive assessment of participants with moderate-severe to very severe cognitive impairment (GDS = 5, 6 and 7). This scale allows obtaining a performance profile in each of the cognitive domains evaluated (comportment, attention, language, memory, motor, conceptualization, arithmetic, and visuospatial) and calculating a total score indicative of the degree of cognitive impairment: moderately severe, severe, very severe and profound. Higher scores mean higher cognitive impairment.
Depression in Dementia
Time frame: 4 weeks
The Cornell Scale for Depression in Dementia (CSDD). Mood evaluation: assessment of signs and symptoms of major depression in patients with dementia focusing on the week preceding the interview. The Cornell Scale utilizes two semi-structured comprehensive interviews that elicits information from the patient and the informant. In those cases in which the patient is not able to respond due to the level of cognitive impairment, information is obtained only from the interview with the informant. Total score ranges from 0 to 38; above 10 indicate a probable major depression and above 18 indicates a definite major depression.
Mood and behaviour
Time frame: 4 weeks
Neuropsychiatric Inventory Questionnaire (NPI-Q). Mood and behavior evaluation: a brief retrospective (1 month) caregiver self-administered questionnaire to assess caregiver distress and severity of 12 neuropsychiatric symptoms: delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating disturbances. For each of the symptoms the informant rates both its severity on a 3-point scale and the associated caregiver distress on a 5-point scale. The NPI-Q provides symptom severity and distress ratings for each symptom reported, and scores for total severity (0 to 36 points) and total distress (0 to 60 points) reflecting the sum of individual domain scores. Higher scores indicate higher severity and caregiver distress.
Agitation
Time frame: 4 weeks
Cohen-Mansfield Agitation Inventory (CMAI). Mood and behavior evaluation: a caregiver rating questionnaire for the assessment of the frequency of manifestations of agitated behaviors. Ratings refer to the two weeks prior to its administration. The CMAI consists of 29 agitated behaviors, each rated on a 7-point frequency scale (ranging from 1-Never to 7-Several times an hour), with higher scores indicating more agitation.
Anxiety
Time frame: 4 weeks
Rating for Anxiety in Dementia (RAID). Mood and behavior evaluation: a clinical rating scale to evaluate severity of anxiety including somatic symptoms and specific fears. Scoring should be based on the two weeks prior to the caregiver interview. The total score ranges from 0 to 40, with higher scores implying greater severity of anxiety disorder.
Sleep-disturbed behaviours
Time frame: 4 weeks
Sleep Disorders Inventory (SDI). Sleep evaluation: this inventory is an expanded version of one item of the Neuropsychiatric Inventory (NPI). It records the frequency (ranging from 0 to 4), the severity (from 0 to 3), and the caregiver distress (from 0 to 5) with respect to eight sleep-disturbed behaviors referred to the two weeks prior to its administration. Higher SDI scores mean greater frequency and severity of sleep disturbances.
Sleep-Actigraphy
Time frame: 4 weeks
Actiwatch AW4 - Actigraphy. Sleep evaluation: actigraphy is a non-invasive method of monitoring circadian rhythm. Actiwatchs are worn on the non-dominant wrist of the participants and record movements that are used to estimate sleep parameters with specialized algorithms in computer software programs. Both experimental and control group participants wore the actiwatch for 5 days before and 5 days after the intervention. Among the parameters obtained from actigraphy records, the following were chosen for analysis in the present study: sleep latency, sleep efficiency and total sleep
Disease severity in advanced stages of dementia.
Time frame: 4 weeks
Bedford Alzheimer Nursing Severity Scale (BANS-S). Functional evaluation: a nursing-staff administered questionnaire for the assessment of disease severity in advanced stages of dementia. The questionnaire comprises 7 items: dressing, sleep-wake cycle disturbances, speech, eating, ambulating, muscle rigidity and eye contact. BANS-S total score ranges from 7 to 28 and higher scores means higher dementia severity.
Mood and behaviour during, preceding and immediately after the sessions
Time frame: 4 weeks
Interact scale. Mood and behavior evaluation: the Interact Scale, and its shortened version, named Interact short, were used for the evaluation of immediate effects in the experimental group. Both allow the assessment of changes in mood and behavior, the Interact scale during the sessions, and the Interact short scale in the 10 minutes immediately preceding and in the 10 minutes immediately following the session. Each of the items is evaluated on a 5-option answer scale ranging from "not al all" to "Nearly all the time". Higher scores mean a higher frequency of occurrence of each type of mood and behavior evaluated.
Mean Heart rate
Time frame: 4 weeks
The baseline hemodynamic state is characterized by storing the mean of the three lowest values for thirty seconds of heart rate (HRrest; in BPM, beats per minute) with a finger pulse oximeter.
Percentage of Oxygen saturation
Time frame: 4 weeks
Blood oxygen saturation (%) of the participants in the experimental group is recorded at the beginning and end of each session using a mobile finger pulse oximeter.
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 8 Jul 2021.
- Background: PubMed 28302633Abraha I, Rimland JM, Trotta FM, Dell'Aquila G, Cruz-Jentoft A, Petrovic M, Gudmundsson A, Soiza R, O'Mahony D, Guaita A, Cherubini A. Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series. BMJ Open. 2017 Mar 16;7(3):e012759. doi: 10.1136/bmjopen-2016-012759.
- Background: PubMed 29143695Dyer SM, Harrison SL, Laver K, Whitehead C, Crotty M. An overview of systematic reviews of pharmacological and non-pharmacological interventions for the treatment of behavioral and psychological symptoms of dementia. Int Psychogeriatr. 2018 Mar;30(3):295-309. doi: 10.1017/S1041610217002344. Epub 2017 Nov 16.
- Background: PubMed 24574061Forbes D, Blake CM, Thiessen EJ, Peacock S, Hawranik P. Light therapy for improving cognition, activities of daily living, sleep, challenging behaviour, and psychiatric disturbances in dementia. Cochrane Database Syst Rev. 2014 Feb 26;2014(2):CD003946. doi: 10.1002/14651858.CD003946.pub4.
- Background: PubMed 10784462Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14. doi: 10.1176/appi.ajp.157.5.708.
- Background: PubMed 24285919Sloane PD, Figueiro M, Cohen L. Light as Therapy for Sleep Disorders and Depression in Older Adults. Clin Geriatr. 2008 Mar 1;16(3):25-31. No abstract available.
- Background: PubMed 17607801Steinberg M, Shao H, Zandi P, Lyketsos CG, Welsh-Bohmer KA, Norton MC, Breitner JC, Steffens DC, Tschanz JT; Cache County Investigators. Point and 5-year period prevalence of neuropsychiatric symptoms in dementia: the Cache County Study. Int J Geriatr Psychiatry. 2008 Feb;23(2):170-7. doi: 10.1002/gps.1858.
- Background: PubMed 26606319van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9.
- Derived from this study: PubMed 34442202Cibeira N, Maseda A, Lorenzo-Lopez L, Gonzalez-Abraldes I, Lopez-Lopez R, Rodriguez-Villamil JL, Millan-Calenti JC. Bright Light Therapy in Older Adults with Moderate to Very Severe Dementia: Immediate Effects on Behavior, Mood, and Physiological Parameters. Healthcare (Basel). 2021 Aug 19;9(8):1065. doi: 10.3390/healthcare9081065.
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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.
José C. Millán-Calenti principal investigator
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light therapy in people with Dementia and Mood, run by Universidade da Coruña at 1 site in Spain.
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 3 inclusion and 3 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 8 Jul 2021. 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 Spain. 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.
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?
Age (time frame: 4 weeks). The study lists 17 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 NCT04949984, which also lists 8 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 8 Jul 2021.