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. 2023 Jan 3;2023(1):CD011881. doi: 10.1002/14651858.CD011881.pub2

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:
  • female

  • medical diagnosis of presumed Alzheimer's disease (mild to severe)

  • inability to sleep through the night and inability to stay awake for daytime activities or meals as reported by staff to occur ≥ 3 times weekly

  • institutionalised in current facility ≥ 6 months

  • medically stable for the last 4 weeks


Exclusion criteria:
  • treatment with light within the last 3 months

  • history of photophobia

  • diagnosis of the following: schizophrenia, Parkinson's disease, bipolar disorder, cancer diagnosis receiving treatment, other dementias, macular degeneration, retinitis pigmentosa, diabetic retinopathy, blindness

  • receiving antihistamines, antiemetics, corticosteroids, dopaminergics, lithium, sedative hypnotics


Number of participants completing the study: 20 (IG 10, CG 10)
Baseline characteristics:
  • age (years, mean): 85.9 (SD 6.24)

  • 18 (90%) Caucasian

  • MMSE (mean): 1.95 (SD 2.86)

  • 18 (90%) widowed

  • length of stay in the care facility (months, mean): 30.85 (SD 18.22)

  • 16 (80%) had 1 roommate

  • 7 (35%) in assisted living and 13 (65%) in long‐term care.


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
  • Sleep efficiency (actigraphy)

  • Sleep fragmentation (actigraphy)

  • Excessive daytime sleep (Stanford Sleepiness Scale)

Funding
  • Dissertation award from Graduate School

  • College of Nursing at Wayne State University

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.