Gasio 2003.
| Methods | Participants randomly assigned to one of two groups: 1) dawn‐dusk simulation (DDS) light therapy (n=9) or 2) 'placebo' dim red light (DRL) (control group) (n=4). Total = 13 Single‐blind |
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| Participants | Country: Switzerland
13 nursing home residents (12 women, 1 man) mean age 85.6 years Group 1: Dawn‐Dusk Simulation Age mean 86.8 (SD 4.5) MMSE mean 13.8 (SD 5.9) Probable AD (n=7) Probable Vascular (n=2) Group 2: Dim Red Light. control group Age mean 83.0 (SD 5.2) MMSE mean 14.3 (SD 4.1) Probable AD (n=3) Lewy body (n=1) |
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| Interventions | Dawn‐Dusk Simulation using an overhead halogen lamp placed behind a diffusing membrane behind the resident's bed simulating a naturalistic form of light therapy Group 1: DDS max 400 Lux morning and evening Group 2 (control): used the same simulation parameters but replaced the white light with a 15W red light bulb. DRL < 5 Lux morning and evening Treatment time varied to mimic the duration and latitude of dawn and dusk Baseline data: 3 weeks Duration of the treatment: 3 weeks Follow up: 3 weeks post‐treatment |
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| Outcomes | Cognition (using the MMSE); depression (using the GDS); sleep latency, sleep duration, and night time activity measured after 3 weeks of treatment and then 3 weeks of follow‐up | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The researchers went through the case histories of residents with the physicians to determine who fit the study criteria and then used a computer‐generated assignment (e‐mail from author, March 26, 2013) |
| Allocation concealment (selection bias) | Low risk | A computer generated randomization to assign residents into the two groups (email from author, March 26, 2013) The group sizes were not balanced as a result of the randomization |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Nurses and participants were blinded (e‐mail from author, March 26, 2013) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Two independent raters estimated daily times of going to bed and getting up, with the help of the nurses’ logs |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Very small sample size Thirteen participants completed the study and seven dropped out due to non‐compliance with wearing the actimeter, fear of the DDS installation, or illness. The attrition may be due to the intervention itself |
| Selective reporting (reporting bias) | High risk | Inconsistent descriptions; in some cases if results were not significant, no t‐scores or p‐values were mentioned, but in other cases of non‐significance they were mentioned |
| Other bias | Low risk | Compliance with wearing the activity monitor was reported |