Ancoli‐Israel 2003a/b.
Methods | Note: Ancoli‐Israel 2003a and Ancoli‐Israel 2003b articles report on the same trial. Ancoli‐Israel 2003a reports on the outcome of the effect of light on sleep, Ancoli‐Israel 2003b reports on the outcome of the effect of bright light therapy on agitated behaviour. Participants randomly assigned to one of three groups: 1) morning bright light (n=30), 2) evening bright light (n=31), or 3) morning dim red light (control) (n=31) Total = 92 Single blind (although nursing and research staff were told that both the white and red light conditions were expected to show improvement and the study was examining which colour light would be better) Residents were stratified by time of agitation |
|
Participants | Country: USA 92 nursing home residents (63 women, 29 men); mean age 82.3 years (SD 7.6, range 61‐99); MMSE mean=5.7 (SD 5.6, range 0‐22) | |
Interventions | Apollo "Brite‐Lite" box placed 1m from resident 1. Bright light > 2500 Lux: time of day 9.30‐11.30 or 17.30‐19.30 2. Dim, red light (control)< 300 Lux: time of day 9.30‐11.30 Received treatment daily Baseline data: three days Duration of treatment: 10 days Follow up: five days post‐treatment Control: The goal of group 2, morning dim red light, was to “act as control for placebo effects and for effects of staff‐patient interaction during treatment sessions” |
|
Outcomes | Sleep: sleep duration, sleep efficiency, night‐time activity measured after 10 days of treatment Agitation: assessed using ABRS and CMAI measured after 10 days of treatment |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block stratified randomization using pre‐assignment by order of entry within the strata |
Allocation concealment (selection bias) | Low risk | Participants were allocated via a random assignment computer generated by a statistician (e‐mail from author, March 26, 2013) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Although nursing staff and research staff could not be kept blind to light treatment condition, they were told the study was examining which colour light was better |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Although nursing staff and research staff could not be kept blind to light treatment condition, they were told the study was examining which colour light was better |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study a: 72 of 92 completed the study Study b: attrition from each group reported in Table 3 study (confirmed by author in March 26, 2013 e‐mail). Similar across the groups but reasons for attrition not specified. Reasons for attrition not specified |
Selective reporting (reporting bias) | Low risk | Outcomes reported. |
Other bias | Low risk | None apparent. There were no significant differences in compliance across light treatment conditions. Treatment compliance: mean 92.1min. of bright light per 120‐min. bright light session. Actillumes worn by 91.3% of participants. |