Chronic insomnia: integrative approaches with auriculotherapy and laser acupuncture to improve sleep

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2025
INTERVENTION: This is a randomized, controlled, analytical, longitudinal, and prospective clinical trial that will include intervention and placebo groups. The total sample will consist of 168 individuals, randomly allocated into si Xdistinct groups, each group with 28 participants. Participants will not be aware of the nature of the treatment received (active intervention or placebo), thus making it a single‐blind study. The monitoring of clinical outcomes will be assessed using validated instruments: the Pittsburgh Sleep Quality Inde Xand the Epworth Sleepiness Scale. The data obtained will be statistically analyzed to verify the effectiveness of the interventions, comparing the scores of the treated and control groups. Each participant in group G1 will undergo 12 sessions of genuine Auriculotherapy, 3 times per week. Each participant in group G2 will undergo 12 sessions of placebo Auriculotherapy, 3 times per week. Each participant in group G3 will undergo 12 sessions of genuine systemic Laser Acupuncture, 3 times per week. Each participant in group G4 will undergo 12 sessions of placebo systemic Laser Acupuncture, 3 times per week. Each participant in group G5 will undergo 12 sessions of genuine Auriculotherapy and 12 sessions of genuine Systemic Laser Acupuncture, 3 times per week. Each participant in group G6 will undergo 12 sessions of placebo Auriculotherapy and 12 sessions of placebo systemic Laser Acupuncture, 3 times per week CONDITION: G47 Sleep deprivation; Disorders of excessive somnolence PRIMARY OUTCOME: This study aims to describe the effectiveness of auriculotherapy and systemic laser acupuncture as alternative treatments for chronic insomnia SECONDARY OUTCOME: No secondary outcome INCLUSION CRITERIA: Age between 18 and 70 years; male and female gender; with spontaneous complaint of insomnia; agree to participate in the research by signing the Informed Consent Form; agree to provide a urine sample for biochemical and toxicological analyses; meet the clinical criteria for chronic insomnia as assessed in the anamnesis; receive diagnostic confirmation of chronic insomnia from a medical professional who is part of the research team; be available to attend all treatment sessions uninterruptedly; obtain a score equal to or greater than 5 points on the questionnaire Pittsburgh Sleep Quality Index, Brazilian version
Epistemonikos ID: 4d93f3499f9b9e40e890447eaf47d42b7f2cec5c
First added on: Jan 24, 2026