Effects of acupuncture on the hypothalamus-pituitary-adrenal axis in chronic insomnia patients: a study protocol for a randomized controlled trial

Table 1 Schedule of enrolment, interventions, and assessments

	Baseline	Intervention		P-T	F-U
	-1 week	0 day	4 weeks	P-T	8 weeks
Enrolment
Eligibility screen	X
Informed consent	X
Medical history	X
Physical examination	X			X	X
Allocation	X
Intervention
Acupuncture group (n = 30)		12 sessions of acupuncture in acupoints
Sham acupuncture group (n = 30)		12 sessions of acupuncture with no skin penetration
Outcomes
PSQI, ISI, FSS	X			X	X
CRH, ACTH, CORT	X			X
Others
Success of blinding				X
Adverse events check		X	X	X	X

PSQI Pittsburgh Sleep Quality Index, ISI Insomnia Severity Index, FSS Fatigue Severity Scale, CRH corticotropin-releasing hormone, ACTH adrenocorticotropic hormone, CORT cortisol, P-T post-treatment, F-U follow-up

ISSN: 1745-6215