Camargos 2014.

Methods	RCT, 2 parallel treatment groups
Participants	Number of participants: 36 randomised, data available for 30 Country: Brazil Setting: outpatients of a Geriatric Medical Centre Diagnosis: probable AD (NINCDS‐ADRDA criteria) Sleep‐related inclusion criteria: insomnia ‐ complained of by patient or observed by caregiver; researcher judged the insomnia to be due to the dementia; the sleep disorder caused emotional distress to the caregiver (NPI 2 or more) Gender: 20 women, 10 men Age: 81.0 ± 7.5 Severity of dementia: MMSE 11.2 ± 6.2
Interventions	Trazodone 50 mg, or placebo
Outcomes	Single actigraph records were created for the 7 to 9 day screening/baseline and 2‐week treatment periods Primary: nTST night‐time waking after sleep onset night‐time number of awakenings daytime total sleep time number of daytime naps (> 10 minutes) night‐time percent sleep (sleep efficiency) gain of > 30 minutes in nTST Secondary: cognitive function (MMSE, Paired Assoicate Learning Test forms I & II of Wechsler Memory Scale, Digit Span Test, Arithmetic, Letter‐Number Sequencing, Digit Symbol‐Coding, and Symbol Search of the Wechsler Adult Intelligence Scale (third edition, WAIS‐III) activities of daily living (Katz Index of Independence in Activities of Daily Living) tolerability and side effects (collected by spontaneous report) subjective analysis of sleep improvement by caregiver
Notes	Adherence to treatment was > 85% in all participants Non‐commercial funding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Online random number generator (www.random.org) was used by one investigator to produce random alphanumeric, 3‐digit codes. These then were used by external pharmacist to label pill bottles. Bottles were handed "in scrambled order" to clinical pharmacist to dispense.
Allocation concealment (selection bias)	Low risk	Allocation sequence known only to one investigator who took no further part in study, inaccessible to recruiting clinicians or clinical pharmacist
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Both the medication pills and the equivalent placebos were received in bulk from the sole manufacturer of trazodone in Brazil (Apsen Laboratory®), and the placebos were prepared to be indistinguishable in appearance with trazodone prepared as 50‐mg pills. The bottles of trazodone or placebo had the same size." "All patients and geriatricians were blinded to the treatment assignment."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"All patients and geriatricians" [outcome assessors] "were blinded to the treatment assignment, and the final randomization list was not accessed until the clinical database was completed" (confirmed by author to mean after actigraphic analysis was completed)
Incomplete outcome data (attrition bias) All outcomes	Low risk	After randomisation, 1 participant was excluded from each group for clinical reasons (heart failure secondary to non­compliance with other medication, episode of agitation leading to arm fracture), and 4 participants (3 trazodone, 1 placebo) due to technical failure of actigraphy. We judged these exclusions to be unlikely to lead to bias
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	None identified