Hozumi 1996.

Study characteristics
Methods	Study design: RCT Follow‐up: day 14
Participants	Country: Japan Setting: 1 hospital Inclusion criteria: dementia irregular sleep–wake patterns in conjunction with nocturnal behaviour disorders or delirium, or both Exclusion criteria: sleep apnoea people reacting with obvious anxiety and distress at any time during the study Number of participants completing the study: 27 (IG 14, CG 13) Baseline characteristics: gender (female): IG 8, CG 7 aged 58–69 years: IG 3, CG 3; aged 70–79 years: IG 2, CG 8; aged ≥ 80 years: IG 9, CG 2 severity 'marked': IG 0, CG 1; 'fair': IG 8, CG 4; 'moderate': IG 7, CG 7; 'mild': IG 1, CG 1 Group differences: no differences reported or identified
Interventions	Intervention: 20 minutes of daily transcranial electrostimulation using a HESS‐100 device (electrodes attached through a headband) for 2 weeks at 10:00 a.m. (rectangular monophasic pulses of 0.2 ms duration and 6–8 V at increasing frequencies from 6 to 80 Hz, with a root mean square value of 256–530 µA). Control: placebo therapy without electric current
Outcomes	Sleep disorder (observation and sleep diary)
Funding	Sponsorship source: Sasakawa Health Science Foundation Japan Foundation for Aging and Health Grant‐in‐Aid for the Research and Development Project of New Medical Technology in Artificial Organs, Ministry of Health and Welfare Japan
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Unclear risk	The participants were randomly assigned to the 2 subgroups, the active therapy group (14 participants) and the placebo therapy group (13 participants).
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	Unclear risk	All evaluations were made by the same doctor and nurse throughout the experimental period. No information other than "double‐blind" and unclear if clinicians performing assessment were blinded.
Blinding of outcome assessors Subjective sleep quality (carer ratings)	Unclear risk	No information available.
Incomplete outcome data All outcomes	High risk	People who reacted with obvious anxiety and distress at any time during the study were excluded. No information about the number of randomised participants or participants excluded during the study.
Selective outcome reporting	Unclear risk	No protocol identified.
Other sources of bias	Low risk	None.