Table 1.
A summary of assessments completed throughout the investigation
| Measure (ordered first to last) | Screening | Treatment session 1–3 | ||
| At-home sleep monitoring | Night | Day | ||
| Informed consent | · | |||
| Medical examination | · | · | ||
| Baseline questionnaires (ISI, ESS, HADS and PHQ-9) | · | |||
| ECG | · | |||
| Urinary drug and alcohol screen | · | · | ||
| Pregnancy test | · | · | ||
| Overnight polysomnography (clinical EEG) | · | · | ||
| Actigraphy | · | |||
| Sleep diary (KSD) | · | |||
| Oral fluid drug screen (Securetech DrugWipe) | · | · | ||
| Quantisal saliva collection | · | · | ||
| Blood plasma collection | · | · | ||
| Urine collection | · | · | ||
| Mood (POMS) | · | · | ||
| Drug effects (DEQ) | · | · | ||
| Balance (posturography) | · | · | ||
| Memory (FTT and WPT) | · | · | ||
| KDT with EEG | · | · | ||
| Sleep questionnaires (LSEQ, RCSQ and KSS) | · | |||
| Simulated driving performance | · | |||
| PVT | · | |||
DEQ, Drug Effects Questionnaire; ECG, electrocardiogram; EEG, electroencephalography; ESS, Epworth Sleepiness Scale; FTT, Finger Tapping Task; HADS, Hospital Anxiety Depression Scale; ISI, Insomnia Severity Index; KDT, Karolinska Drowsiness Test; KSD, Karolinska Sleep Diary; KSS, Karolinska Sleepiness Scale; LSEQ, Leeds Sleep Evaluation Questionnaire; PHQ-9, Patient Health Questionnaire-9; POMS, Profile of Mood States; PSG, polysomnography; PVT, Psychomotor Vigilance Task; RCSQ, Richard Campbell Sleep Questionnaire; WPT, Word Pairs Task.