Table 1.

Outcome Measures

Outcome measure	Frequency	Tool used
Sleep Quality and Quantity	Baseline, day 5, weeks 2, 4 & 8	PSQI, Polar A370 sleep monitor (wrist actigraphy) and the consensus sleep diary
Sleep onset latency	Baseline, day 5, weeks 2, 4 & 8	Consensus sleep diary
Sleep disturbance (waking during the night or waking too early)	Baseline, day 5, weeks 2, 4 & 8	Wrist actigraphy, consensus sleep diary and the PROMIS sleep disturbance questionnaire
Sleep inertia	Baseline, day 5, weeks 2, 4 & 8	SIQ and wrist actigraphy
Daytime sleepiness	Baseline, day 5, weeks 2, 4 & 8	SIQ and consensus sleep diary
Morning grogginess on waking	Baseline, day 5, weeks 2, 4 & 8	SIQ and consensus sleep diary
Daytime nap count and duration	Baseline, day 5, weeks 2, 4 & 8	ESS and consensus sleep diary
General quality of life	Baseline, day 5, weeks 2, 4 & 8	SF-36
Pathology and Safety markers	Baseline and week 8	Albumin, ALT, AST, GGT, total bilirubin, hsCRP, IL10, IL6, IL8 and TNFa
Adverse events	Continuously	Spontaneously reported by the participant or noticed by a trial supervisor

PSQI Global Pittsburgh Sleep Quality Index, PROMIS Patient Reported Outcomes Measurement Information System, SIQ The Sleep Inertia Questionnaire, ESS Epworth Sleepiness Scale, SF-36 Rand 36-item Health Survey, ALT Alanintransaminase, AST Aspartate Transaminase, GGT Gamma-Glutamyl Transferase, hsCRP high sensitivity C-reactive Protein, IL interleukin, TNF Tumor Necrosis Factor