Fontana Gasio 2003.

Study characteristics
Methods	Study design: RCT Follow‐up: 4–6 weeks
Participants	Country: Switzerland, Basel Setting: 2 long‐term care facilities and 1 hospital Inclusion criteria: men or women aged > 65 years symptoms/diagnosis of dementia sleep disturbances (validated by health professionals) Exclusion criteria: people with medical illness or other problems Number of participants completing the study: 13 (IG 9, CG 4) Baseline characteristics: age (years, mean): IG 86.8 (SD 4.5), CG 83.0 (SD 5.2) MMSE total score (mean): IG 13.8 (SD 5.9), CG 14.3 (SD 4.1) Group differences: no means reported
Interventions	Intervention: dawn‐dusk simulation for 1 week. An overhead halogen lamp behind a diffusing membrane was placed behind the participant's bed. A computer algorithm controlled this lamp, exposing the participant to light ranging from 0.001 lux to a maximum of 400 lux, simulating a dusk, dawn, and dark period. Control: placebo dim red light (white light replaced with a "placebo" 15 W red‐light bulb yielding 5 lux) for 1 week
Outcomes	Night‐time total sleep, hours/minutes (actigraphy) Sleep efficiency (actigraphy) Sleep latency (actigraphy) Number of sleep bouts (actigraphy)
Funding	Sponsorship source: Velux Foundation
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Unclear risk	13 inpatients with the diagnosis of dementia and with nurse‐reported sleep disturbances were randomly assigned to a regimen of DDS (9 women, aged 86.8 (SD 4.5) years, MMSE: 13.8 (SD 5.9)) or 'placebo' dim red light (5 lux; 4 participants (3 women and 1 man), aged 83.0 (SD 5.2) years, MMSE: 14.3 (SD 4.1)). No further information given.
Allocation concealment	Unclear risk	No information given.
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	Low risk	Actimetry.
Blinding of outcome assessors Subjective sleep quality (carer ratings)	Unclear risk	No information available.
Incomplete outcome data All outcomes	Low risk	Arose by chance from the original randomisation scheme for 40 participants. Judgement comment: no information, but seemingly all 13 randomised were still there at follow‐up. Imbalance in participant numbers between groups explained by initial sample size of 40.
Selective outcome reporting	Unclear risk	No protocol identified.
Other sources of bias	High risk	The low number in the second group arose by chance from the original randomisation scheme for 40 participants. The group size was not balanced by the time they realised that the required number of participants could not be recruited. All wore an activity/lux monitor continuously. Sample size calculation, 40 participants, recruited 13. Group imbalance (IG 9, CG 4) with unclear relevance