Trial Outcomes & Findings for Population Based Lighting Study on Older Adults (NCT NCT05676086)
NCT ID: NCT05676086
Last Updated: 2026-05-26
Results Overview
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse). A score \<= 5 is associated with good sleep quality, while a score \> 5 is associated with poor sleep quality. A higher PSQI score indicates poorer sleep quality, therefore the hypothesis to be tested is that a participant's sleep quality will improve (i.e. PSQI score will decrease) at the end of the light intervention period compared to baseline. Hence, a negative PSQI difference between baseline and follow-up indicates an improvement in sleep quality.
COMPLETED
NA
191 participants
from baseline to the end of the light intervention period - 16 weeks
2026-05-26
Participant Flow
Participant milestones
| Measure |
Indoor Light Intervention
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
93
|
|
Overall Study
COMPLETED
|
84
|
85
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
| Measure |
Indoor Light Intervention
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
8
|
Baseline Characteristics
2 participants had missing data
Baseline characteristics by cohort
| Measure |
Indoor Light Intervention
n=98 Participants
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
n=93 Participants
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 Years
n=98 Participants
|
73 Years
n=93 Participants
|
73 Years
n=191 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=96 Participants • 2 participants had missing data
|
65 Participants
n=93 Participants • 2 participants had missing data
|
134 Participants
n=189 Participants • 2 participants had missing data
|
|
Sex: Female, Male
Male
|
27 Participants
n=96 Participants • 2 participants had missing data
|
28 Participants
n=93 Participants • 2 participants had missing data
|
55 Participants
n=189 Participants • 2 participants had missing data
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
9 Participants
n=98 Participants
|
5 Participants
n=93 Participants
|
14 Participants
n=191 Participants
|
|
Region of Enrollment
Italy
|
33 Participants
n=98 Participants
|
33 Participants
n=93 Participants
|
66 Participants
n=191 Participants
|
|
Region of Enrollment
Estonia
|
56 Participants
n=98 Participants
|
55 Participants
n=93 Participants
|
111 Participants
n=191 Participants
|
|
Impact of electric light on sleep quality as measured with the Pittsburgh Sleep Quality Index (PSQI)
|
5 Score on a scale
n=98 Participants
|
6 Score on a scale
n=93 Participants
|
5 Score on a scale
n=191 Participants
|
|
EuroQol 5D
|
0.91 Score on a scale
n=98 Participants
|
0.91 Score on a scale
n=93 Participants
|
0.91 Score on a scale
n=191 Participants
|
|
Dim Light Melatonin Onset (DLMO)
|
21.67 Clock time (hours)
n=98 Participants
|
21.44 Clock time (hours)
n=93 Participants
|
21.61 Clock time (hours)
n=191 Participants
|
|
Circadian rest-activity measures - Interdaily stability (IS)
|
0.50 Normalized index
n=98 Participants
|
0.52 Normalized index
n=93 Participants
|
0.50 Normalized index
n=191 Participants
|
|
Circadian rest-activity measures - Relative amplitude (RA)
|
0.64 Normalized index
n=98 Participants
|
0.63 Normalized index
n=93 Participants
|
0.64 Normalized index
n=191 Participants
|
|
Circadian rest-activity measures - Intradaily variability (IV)
|
0.52 Normalized index
n=98 Participants
|
0.55 Normalized index
n=93 Participants
|
0.53 Normalized index
n=191 Participants
|
PRIMARY outcome
Timeframe: from baseline to the end of the light intervention period - 16 weeksPittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse). A score \<= 5 is associated with good sleep quality, while a score \> 5 is associated with poor sleep quality. A higher PSQI score indicates poorer sleep quality, therefore the hypothesis to be tested is that a participant's sleep quality will improve (i.e. PSQI score will decrease) at the end of the light intervention period compared to baseline. Hence, a negative PSQI difference between baseline and follow-up indicates an improvement in sleep quality.
Outcome measures
| Measure |
Indoor Light Intervention
n=98 Participants
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home
indoor light intervention: Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
n=93 Participants
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only
no indoor light: Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
|
0 Score change
Interval -1.0 to 2.0
|
0 Score change
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: from baseline to the end of the light intervention period - 16 weeksChange in mental and physical health as measured by Euroqol 5D difference between the baseline and the end of the light intervention period. The Euroqol 5D measures the perceived quality of life and ranges from - 0.57 (worst perceived quality of life) to 1 (best health state). A positive difference from baseline to the end of the follow-up period indicates an improvement in the quality of life.
Outcome measures
| Measure |
Indoor Light Intervention
n=98 Participants
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home
indoor light intervention: Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
n=93 Participants
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only
no indoor light: Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
|---|---|---|
|
Change in Mental and Physical Health (Euroqol 5D)
|
0.00 Score change
Interval 0.0 to 0.06
|
0.00 Score change
Interval -0.05 to 0.04
|
SECONDARY outcome
Timeframe: from baseline to the end of the light intervention period - 16 weeksChange in Interdaily Stability (IS), as derived from wrist actigraph, between the baseline and the end of the light intervention period. Interdaily Stability (IS) is an index that estimates the stability of the 24-hour rest-activity rhythm across days, quantifying how consistent individual's daily pattern is over time. It ranges from 0 (absence of a stable rhythm) to 1 (perfectly stable rhythm). The hypothesis to be tested is that a participant's IS will increase at the end of the light intervention period compared to baseline; hence, a positive difference between baseline and follow-up indicates an improved rest-activity rhythm.
Outcome measures
| Measure |
Indoor Light Intervention
n=98 Participants
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home
indoor light intervention: Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
n=93 Participants
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only
no indoor light: Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
|---|---|---|
|
Change in Circadian Rest-activity Measures - Interdaily Stability (IS)
|
-0.01 Normalized Index
Interval -0.05 to 0.04
|
-0.01 Normalized Index
Interval -0.05 to 0.03
|
SECONDARY outcome
Timeframe: from baseline to the end of the light intervention period - 16 weeksChange in Intradaily Variability (IV), as derived from wrist actigraphy, between the baseline and the end of the light intervention period. Intradaily Variability (IV) is an index that reflects fragmentation of the 24-hour rest-activity rhythm within a day, based on the frequency of transitions between rest and activity. It ranges from 0 to 1, with higher values indicating more fragmented rhythms. The hypothesis to be tested is that a participant's IV will decrease at the end of the light intervention period compared to baseline; hence, a negative difference between baseline and follow-up indicates an improved rest-activity rhythm.
Outcome measures
| Measure |
Indoor Light Intervention
n=98 Participants
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home
indoor light intervention: Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
n=93 Participants
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only
no indoor light: Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
|---|---|---|
|
Change in Circadian Rest-activity Measures - Intradaily Variability (IV)
|
-0.01 Normalized Index
Interval -0.05 to 0.03
|
-0.02 Normalized Index
Interval -0.06 to 0.01
|
SECONDARY outcome
Timeframe: from baseline to the end of the light intervention period - 16 weeksChange in Relative amplitude (RA), as derived from wrist actigraphy, between the baseline and the end of the light intervention period. Relative Amplitude (RA) measures the strength of the 24-hour rhythm: (M10-L5)/(M10+L5). M10 is the mean activity during the 10 most active consecutive hours, and L5 during the 5 least active hours. RA ranges from 0 to 1 and reflects the normalized difference between the most active and least active periods of the day: higher values indicate a well-defined rhythm, lower values a weaker or disrupted rhythm. The hypothesis to be tested is that a participant's RA will increase at the end of the light intervention period compared to baseline; hence, a positive difference between baseline and follow-up indicates an improved rest-activity rhythm.
Outcome measures
| Measure |
Indoor Light Intervention
n=98 Participants
Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home
indoor light intervention: Persons allocated to the indoor light intervention arm will be given a lamp to be placed at home with specific instructions to install it in a room where they spend most of their time, in order to supplement the existing indoor lighting. Thus, all people of the intervention arm will be equipped with the LUMIE Halo lamp. Utilizing both warm-white and cool-white LEDs, Lumie Halo delivers 10,000 lux at 20 cm at maximum brightness in "Day" Mode. The touch slider allows the user to adjust the brightness while mixing the color temperature of the light.
|
Control Group
n=93 Participants
Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only
no indoor light: Persons allocated to the control group will receive no indoor light supplementation and will undergo assessment procedures only. Exposure to the outdoor intervention will be taken into account in the analysis in three ways, (1) by locating the distance between people's home and the modified outdoor light, (2) by a question about the awareness of the change in outdoor light, timing, and duration of exposure and what they think of it, and (3) by recording the amount of light exposure over the 24 hours during two weeks at baseline and after the 1-year light interventions
|
|---|---|---|
|
Change in Circadian Rest-activity Measures - Relative Amplitude (RA)
|
-0.01 Normalized Index
Interval -0.05 to 0.03
|
0.01 Normalized Index
Interval -0.03 to 0.03
|
Adverse Events
Indoor Light Intervention
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Francesco Nonino, MD
Azienda USL di Bologna - IRCCS Istituto delle Scienze Neurologiche di Bologna
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place