The Effect of Bright Light Treatment on Rest–Activity Rhythms in People with Dementia: A 24-Week Cluster Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Sample Size and Power Calculation
2.3. Delivery of the Intervention
2.4. Group Allocation and Blinding
2.5. Measurements
2.5.1. Rest–Activity Rhythms
2.5.2. Light Measurements
2.5.3. Other Measurements
2.6. Data Management and Statistical Analyses
2.7. Ethical Considerations
3. Results
3.1. Sample Descriptive Statistics
3.2. Adherence
3.3. Light Measurements
3.4. Rest–Activity Rhythms
Correlations between Circadian Rhythm Outcomes at Baseline
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Participants Were Eligible If They: | Patients Were Not Eligible If They: |
---|---|
|
|
Control (N = 31) | Intervention (N = 30) | Total (N = 61) | |
---|---|---|---|
Female | 20 (64.5%) | 23 (76.7%) | 43 (70.5%) |
Age—M (Q1, Q3) | 82.0 (78.5, 87.5) | 86.0 (83.0, 88.8) | 84.0 (79.0, 88.0) |
FAST | |||
4 | 0 (0.0%) | 2 (6.7%) | 2 (3.3%) |
5 | 1 (3.3%) | 1 (3.3%) | 2 (3.3%) |
6 | 21 (70.0%) | 24 (80.0%) | 45 (75.0%) |
7 | 8 (26.7%) | 3 (10.0%) | 11 (18.3%) |
CCI—M (Q1, Q3) | 1.0 (1.0, 2.0) | 2.0 (1.0, 2.0) | 1.0 (1.0, 2.0) |
MMSE—M (Q1, Q3) | 4.0 (2.0, 9.0) | 4.0 (1.0, 11.0) | 4.0 (1.0, 10.0) |
Psychotropic med. *—M (Q1, Q3) | 3.0 (2.0, 3.0) | 3.0 (2.0, 4.0) | 3.0 (2.0, 4.0) |
No. using hypnotics/sedatives † | 10 (32.3%) | 12 (40.0%) | 22 (36.1%) |
No. with eye disease | 6 (19.4%) | 4 (13.3%) | 10 (16.4%) |
Dementia diagnoses | |||
Alzheimer’s | 17 (55%) | 16 (53%) | 33 (54%) |
Vascular | 1 (3%) | 2 (7%) | 3 (5%) |
Lewy body | 1 (3%) | 0 (0%) | 1 (2%) |
Other | 1 (3%) | 1 (3%) | 2 (3%) |
Unknown | 9 (29%) | 10 (33%) | 19 (31%) |
IS | IV | RA | M10 | L5 | |
---|---|---|---|---|---|
Amplitude | 0.66 **** | −0.52 **** | 0.6 **** | 0.46 **** | −0.29 * |
MESOR | 0.11 | −0.21 | −0.19 | 0.67 **** | 0.54 * |
Alpha | 0.06 * | −0.26 | 0.15 * | −0.02 | −0.11 **** |
Beta | −0.18 * | 0.26 **** | −0.10 | 0.00 * | 0.02 |
F-statistic | 0.81 **** | −0.58 **** | 0.82 **** | 0.48 **** | −0.49 **** |
Acrophase | 0.14 * | −0.23 * | −0.03 | 0.09 **** | 0.09 |
Nadir | −0.41 **** | 0.32 **** | −0.62 **** | 0.18 | 0.66 **** |
Week 8 × Intervention B (95 % CI) | Week 16 × Intervention B (95 % CI) | Week 24 × Intervention B (95 % CI) | N | N (id) | R2 (Fixed) | R2 (Total) | ICC | |
---|---|---|---|---|---|---|---|---|
Non-Parametric Indicators | ||||||||
IS | −0.01(−0.12–0.10) | −0.02(−0.15–0.10) | 0.02(−0.10–0.13) | 187 | 64 | 0.04 | 0.57 | 0.55 |
IV | −0.07(−0.22–0.09) | −0.02(−0.19–0.15) | −0.08(−0.23–0.07) | 187 | 64 | 0.01 | 0.77 | 0.77 |
RA | −0.07(−0.19–0.05) | −0.05(−0.18–0.08) | −0.04(−0.16–0.09) | 187 | 64 | 0.04 | 0.61 | 0.59 |
M10 | 11.3(−20.62–43.22) | −9.34(−44.51–25.83) | 11.68(−20.04–43.40) | 187 | 64 | 0.13 | 0.75 | 0.71 |
L5 | 8.47(−3.70–20.64) | −1.26(−14.65–12.13) | 2.85(−9.25–14.94) | 187 | 64 | 0.03 | 0.67 | 0.66 |
Extended Cosine Model | ||||||||
Amplitude (ln) | −0.82(−1.81–0.17) | −0.41(−1.52–0.70) | −0.26(−1.28–0.75) | 166 | 61 | 0.02 | 0.32 | 0.31 |
MESOR (ln) | −0.01(−0.44–0.43) | −0.21(−0.70–0.28) | −0.19(−0.64–0.25) | 166 | 61 | 0.05 | 0.45 | 0.42 |
Acrophase * | −0.51(−1.39–0.37) | −1.02(−2.00–−0.05) † | −0.59(−1.49–0.30) | 163 | 61 | 0.10 | 0.63 | 0.59 |
Nadir * | 0.41(−0.02–0.84) | 0.01(−0.47–0.50) | −0.06(−0.50–0.38) | 166 | 60 | 0.04 | 0.52 | 0.49 |
Alpha | −0.12(−0.38–0.14) | −0.14(−0.44–0.16) | −0.19(−0.46–0.08) | 166 | 61 | 0.05 | 0.51 | 0.48 |
Beta (ln) | 0.29(−0.65–1.24) | 0.48(−0.57–1.53) | 0.57(−0.40–1.54) | 165 | 61 | 0.03 | 0.08 | 0.05 |
F-statistic (ln) | −0.4(−0.82–0.03) | −0.01(−0.49–0.47) | −0.06(−0.50–0.38) | 166 | 61 | 0.05 | 0.78 | 0.77 |
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Kolberg, E.; Pallesen, S.; Hjetland, G.J.; Nordhus, I.H.; Flo-Groeneboom, E. The Effect of Bright Light Treatment on Rest–Activity Rhythms in People with Dementia: A 24-Week Cluster Randomized Controlled Trial. Clocks & Sleep 2021, 3, 449-464. https://doi.org/10.3390/clockssleep3030032
Kolberg E, Pallesen S, Hjetland GJ, Nordhus IH, Flo-Groeneboom E. The Effect of Bright Light Treatment on Rest–Activity Rhythms in People with Dementia: A 24-Week Cluster Randomized Controlled Trial. Clocks & Sleep. 2021; 3(3):449-464. https://doi.org/10.3390/clockssleep3030032
Chicago/Turabian StyleKolberg, Eirin, Ståle Pallesen, Gunnhild Johnsen Hjetland, Inger Hilde Nordhus, and Elisabeth Flo-Groeneboom. 2021. "The Effect of Bright Light Treatment on Rest–Activity Rhythms in People with Dementia: A 24-Week Cluster Randomized Controlled Trial" Clocks & Sleep 3, no. 3: 449-464. https://doi.org/10.3390/clockssleep3030032