Table 2

Primary, secondary and exploratory outcomes

		Weeks
	Enrolment (baseline)	9W	21W	35W	61W
Primary outcome
ISI score (change in ISI from baseline to 9-week postrandomisation)		x
Secondary outcomes
Patient-reported outcomes (Hugo)
ISI score	x		x	x	x
ESS	x	x	x	x	x
PHQ-8	x	x	x	x	x
GAD-7	x	x	x	x	x
PSS-10	x	x	x	x	x
SF-12	x	x	x	x	x
Healthcare utilisation outcomes (Hugo)
No. outpatient visits		x	x	x	x
No specialty care visits		x	x	x	x
No. medication refills for sleep		x	x	x	x
No. of medication refills for psychotropic medications		x	x	x	x
Health Utility Scores (Hugo)
Health utility scores (SF-12)		x	x	x	x
Sleep diaries*
SE	x	x	x	x	x
SOL (min)	x	x	x	x	x
WASO (min)	x	x	x	x	x
Number of awakenings	x	x	x	x	x
Sleep quality (scale score)	x	x	x	x	x
Time in bed	x	x	x	x	x
Total sleep time	x	x	x	x	x
Exploratory outcomes (FitBit feature comparisons)
Steps per day	x	x	x	x	x
Sleep (total sleep time in minutes)	x	x	x	x	x
Weight	x	x	x	x	x
Height	x	x	x	x	x
Body mass index	x	x	x	x	x

*Definition of key sleep outcomes:
SE: The ratio of TST to TIB.
SOL: The length of time that it takes between ‘lights out’ or intention to sleep and first onset of sleep.
Sleep quality: One's satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment on awakening.
WASO: Total time awake between initial sleep onset and final morning awakening.
ESS, Epworth Sleepiness Scale; GAD-7, Generalized Anxiety Disorder-7; ISI, insomnia severity index; PHQ-8, Patient Health Questionnaire-8; PSS, Perceived Stress Scale; SE, sleep efficiency; SF, Short-Form; SOL, sleep onset latency; TIB, time in bed; TST, total sleep time; WASO, waking after sleep onset.