Table 2 Physiological, objective, and subjective variables collected during the study
| Â | Continuous e-monitoring (Oura Ring) | Self-reports (DASI, MEQ, ASRS, PHQ-9, Visual analog scale) | Clinician ratings (MADRS, YMRS) |
|---|---|---|---|
Physiological | HR and HRV: average HR for each 5 mins of sleep period; lowest HR registered during sleep; average HR during the sleep period; HRV using RMSSD during the night and for each 5 mins of sleep period. | Â | Â |
Objective | Sleep: local time when sleep starts and ends; onset latency; total duration of sleep; total duration of awakenings during sleep period; sleep efficiency; total amount of light, deep- and REM-sleep; restlessness (percentage of sleep time when movement was detected). Activity: local time when local activity starts and ends; number of minutes during the day with low, medium, and high activity; number of inactive minutes during the day; number of minutes during the day when the user was resting (lying down or napping); number of minutes during the day when the user was not wearing the ring; total number of steps during the day. Energy: energy consumption (MET) during low, medium, and high activity periods and during the day. | Â | Baseline and end of study: MADRS: observed sadness. YMRS: observed motor activity, irritability, rate and amount of speech, disordered language or thought, thought content, disruptive or aggressive behavior, appearance, insight. Baseline and throughout the study: Pharmacotherapy questionnaire: name, dose, and date medication started or changed; medication compliance |
Subjective | Â | Baseline: DASI: 12-item questionnaire to assess ability to perform a set of activities (personal care, ambulation, household tasks, sexual activity, recreational activity) to gauge functional cardiovascular capacity. MEQ: 19 multiple-choice questions to determine chronotype. Baseline and weekly: ASRS: 6-item to assess mood, sleep, activity, grandiosity, and talkativeness. PHQ-9: 9-item to assess mood, pleasure (anhedonia); sleep, energy, appetite, guilt, concentration, psychomotor retardation or agitation, thoughts of death or suicide and their impact on functioning. Daily: Visual analog scale: self-rated fluctuations in mood, anxiety, and energy levels for each day | Baseline and end of study: MADRS: reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel, pessimism, suicidal thoughts. YMRS: mood, energy, sexual interest, sleep, irritability |