Week | 0 | 1 | 2 | 3 | 4 | 8 |
Baseline | Treatment phase | Follow-up phase | ||||
Patients | ||||||
Telephone reservation | × | |||||
Enrolment | × | |||||
Sign informed consent | × | |||||
Clinical interview | × | |||||
Sleep scales | × | |||||
Physical examination | × | × | ||||
Laboratory test | × | × | ||||
PSG | × | |||||
Groups | ||||||
Acupuncture group (normal sleep duration) | 10 treatments | |||||
Control group (normal sleep duration) | 10 treatments | |||||
Acupuncture group (short sleep duration) | 10 treatments | |||||
Control group (short sleep duration) | 10 treatments | |||||
Outcome measurement | ||||||
PSQI | × | × | × | |||
ISI | × | × | × | |||
ACT | × | × | ||||
BAI | × | × | ||||
BDI | × | × | ||||
FSS | × | × | ||||
Sleep diary | × | × | × | × | × | |
Success of subject-blinding test | × | |||||
Adverse events | ||||||
Reasons for dropouts or withdrawals | × | × | × | × | × | |
Patient’s compliance | × | × |
ACT, actigraphy; BAI, Beck Anxiety Inventory; BDI, Beck Depression Inventory; FSS, Fatigue Severity Scale; ISI, Insomnia Severity Index; PSG, polysomnography; PSQI, Pittsburgh Sleep Quality Index.