Alessi 2005.

Study characteristics
Methods	Study design: RCT Follow‐up: days 3–5
Participants	Country: USA, Los Angeles Setting: 4 long‐term care facilities Inclusion criteria: ≥ 15% daytime sleep (from 9:00 a.m. to 5:00 p.m.) ≤ 80% night‐time sleep (time asleep over time monitored, 10:00 p.m. to 6:00 a.m.) informed consent Exclusion criteria: acutely ill residents in contact isolation completely bed‐bound Number of participants completing the study: 118 (IG 62, CG 56) Baseline characteristics: age (years, mean): IG 87.8 (SD 7.8), CG 85.9 (SD 10.1) gender (female): IG 77%, CG 77% MMSE score (mean): IG 11.9 (SD 9.2), CG 10.6 (SD 10) Group differences: comparable at baseline
Interventions	Quote: "Intervention research staff provided the intervention for five consecutive days and nights to five to six participants at a time." Intervention: 5 days of: 1. keeping residents out of bed between 8.00 a.m. and 18.00 p.m., and a minimum duration of 30 minutes of sunlight exposure a day (at 10,000 lux); 2. participating in a low‐level physical activity programme 3 times a day; and 3. an individualised bedtime routine (between 20.00 p.m. and 22.00 p.m.), including personal care and reduced light and noise. The study aimed to minimise night‐time noise and light for the whole night (22.00 p.m. to 6.00 a.m.). All aspects of the intervention were documented in detail. Control: usual care
Outcomes	Night‐time total sleep, hours/minutes (actigraphy) Percentage of night‐time sleep (actigraphy) Night‐time number of awakenings (actigraphy) Night‐time mean awakening length, minutes (actigraphy) Daytime sleep (observation)
Funding	Sponsorship source: National Institute on Aging, VA Health Services Research and Development VA Greater Los Angeles Healthcare System Geriatric Research, Education and Clinical Center
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Unclear risk	Quote: "Participants were randomly allocated to intervention or control groups within each site using a random sequence, without blocking or stratification. The generated sequence was used to randomly allocate 53% of the enrolled sample to intervention and 47% to control, because of the a priori expectation of greater drop‐out of intervention participants (20% expected dropout rate) than of controls (10% expected dropout rate)."
Allocation concealment	Unclear risk	No information.
Blinding of participants and personnel All outcomes	Unclear risk	Unknown.
Blinding of participants and personnel Subjective sleep quality (carer ratings)	Unclear risk	Unknown.
Blinding of participants and personnel Objective sleep measures	Unclear risk	Unknown.
Blinding of outcome assessors Objective outcome measures	High risk	Quote: "To minimize bias in assessment, independent research staff completed the assessment and intervention aspects of the study. Research staff who performed outcome assessments could not be adequately blinded to study condition at follow‐up because the characteristics of the intervention were directly observable, although they were blinded to study research questions." Different for outcomes: daytime observations: high; night‐time actigraphy: low.
Blinding of outcome assessors Subjective sleep quality (carer ratings)	Unclear risk	No information available.
Incomplete outcome data All outcomes	Low risk	Fairly balanced.
Selective outcome reporting	Unclear risk	Protocol not identified.
Other sources of bias	High risk	Delayed time series? Follow‐up time in CG twice as long as IG. Also IG received intervention at different points. Contamination as risk? Not possible?