The effect of enhanced external counterpulsation on sleep quality and quality of life in patients with chronic...

Insomnia is highly prevalent in the general population and increases the risk of somatic and mental disorder. It leads to considerable strain on healthcare systems and contributes to societal burdens. Current recommended treatments for chronic insomnia are limited, and a proportion of patients do not respond adequately. Enhanced external counterpulsation (EECP) is an effective and noninvasive therapy for ischemic vascular disease. Findings from our previous pilot trial demonstrated its potential therapeutic effect on chronic insomnia. This current large-scale randomized controlled study aims to investigate the therapeutic efficacy of EECP in chronic insomnia, as well as its underlying mechanisms.

This single-center, two-armed, randomized, single-blinded, parallel sham-controlled trial will enroll 98 participants with chronic insomnia aged 18-75 years. Based on a 1:2 ratio, participants will be randomly assigned to the sham EECP group (control) or the EECP group (experimental) to receive 45-minute sessions. Five sessions will be held per week for a total of 35 sessions. This trial will include six assessments (i.e., pre-intervention, mid-intervention [20th session], post-intervention [35th session], and 3-month, 6-month, and 12-month follow-ups) over 14 months. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) score post-intervention. Secondary outcomes include PSQI score changes at mid-intervention and at 3-, 6-, and 12-month follow-ups; sleep parameters (total sleep time, efficiency, latency, and awakenings); anxiety, depression and quality of life scores at mid-intervention, post-intervention, and follow-ups; along with peak oxygen uptake, heart rate at 1-minute recovery, vascular endothelial function, and blood biomarkers post-intervention.

This study will report on the short-, medium-, and long-term efficacy of EECP in chronic insomnia, as well as its underlying mechanisms. The findings may offer a new treatment option for refractory patients and help improve productivity, reduce comorbidities, and lower healthcare costs.

ChiCTR, ChiCTR2500101872 (URL: https//www.chictr.org.cn/). Registered on 30 April 2025.