Nowak 2008.
Study characteristics | ||
Methods |
Study design: RCT Follow‐up: day 15–19 |
|
Participants |
Country: USA, Southeastern Michigan Setting: long‐term care facility (unclear number) Inclusion criteria:
Exclusion criteria:
Number of participants completing the study: 20 (IG 10, CG 10) Baseline characteristics:
Group differences: none for sleep measures (others not reported) |
|
Interventions |
Intervention: blue–green light exposure to 12,000 lux for 30 minutes between 6 a.m. and 7 a.m. for 14 consecutive days via cap visors. Control: dim red light exposure to 5 lux for 30 minutes between 6 a.m. and 7 a.m. for 14 consecutive days via cap visors. |
|
Outcomes |
|
|
Funding |
|
|
Notes | PhD thesis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence generation | Unclear risk | Quote: "… randomized to either the experimental condition or control group utilizing a five‐block randomized block design (Appendix F)" (p.54). |
Allocation concealment | Unclear risk | Not reported. |
Blinding of participants and personnel All outcomes | Unclear risk | All interventions and outcome assessment actions were performed by the principal investigator. |
Blinding of participants and personnel Subjective sleep quality (carer ratings) | High risk | Quote: (post‐test and follow‐up) "The SSS was completed by the PI [principal investigator] as noted in Phase 2 three times per day (at meal times) for five consecutive days beginning on day 1 of the follow‐up period." (by telephone or by direct observation) (p.56/57). Unblinded staff assessed the outcomes. |
Blinding of participants and personnel Objective sleep measures | Low risk | Actigraphy. |
Blinding of outcome assessors Objective outcome measures | Low risk | Actigraphy. |
Blinding of outcome assessors Subjective sleep quality (carer ratings) | High risk | Quote: (post‐test and follow‐up) "The SSS was completed by the PI as noted in Phase 2 three times per day (at meal times) for five consecutive days beginning on day 1 of the follow‐up period" (by telephone or by direct observation) (p.56/57). Unblinded staff assessed these outcomes. |
Incomplete outcome data All outcomes | Low risk | Dropout rate: 1/21 (p.105). |
Selective outcome reporting | Unclear risk | Study was not registered and no protocol was published. |
Other sources of bias | Low risk | None. |