1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [paulferdin555@gmail.com].
   


6. For how long will this data be available start date provided 30-06-2026 and end date provided 31-12-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Introduction: Insomnia is a widespread sleep disorder where individuals face difficulty falling or staying asleep. It affects a significant portion of the adult population, contributing to issues such as poor quality of life, emotional disturbances, and decreased work performance. Insomnia can be classified as short-term (lasting days or weeks) or long-term (more than three months) and can lead to serious health consequences, including cardiovascular disease, obesity, and diabetes.

The regulation of sleep is influenced by both homeostatic and circadian processes, and disruptions to these can lead to insomnia. Acupuncture, a form of Traditional Chinese Medicine (TCM), has been explored as a potential treatment, involving the stimulation of specific acupoints to promote healing and balance in the body. This study focuses on evaluating the effectiveness of acupuncture at Extraordinary Points 8 and 9 (Ex-8 and Ex-9) in improving sleep quality among patients with primary insomnia.

Literature Review: Several studies have investigated the effectiveness of acupuncture in treating insomnia. Research indicates that acupuncture can improve sleep by stimulating specific acupoints, such as Shenmen (HT 7), Sanyinjiao (SP 6), and others. These studies have shown positive results in terms of enhancing sleep efficiency, reducing the time taken to fall asleep, and improving sleep quality. However, few studies have focused specifically on Ex-8 and Ex-9 acupoints, and this study aims to address that gap.

Research Aim and Objectives:

• Aim: To assess the efficacy of acupuncture at Extraordinary Points 8 and 9 on sleep quality in insomnia patients.
• Primary Objective: To determine the impact of acupuncture at Ex-8 and Ex-9 on sleep quality.
• Secondary Objective: To evaluate the effect of acupuncture on heart rate variability (HRV) in insomnia patients.

Research Question and Hypothesis:

• Research Question: Does acupuncture at Ex-8 and Ex-9 improve sleep quality and HRV in primary insomnia patients?
• Null Hypothesis: Acupuncture at Ex-8 and Ex-9 does not improve sleep quality or HRV.
• Alternate Hypothesis: Acupuncture at Ex-8 and Ex-9 improves sleep quality and HRV.

Materials and Methods:

• Study Design: A randomized controlled trial (RCT) will be conducted with 60 patients, divided into two groups (study and control). The study group will receive acupuncture at Ex-8 and Ex-9, while the control group will receive sham acupuncture.

• Participants:

  • Inclusion Criteria: Adults aged 20–60 years, diagnosed with primary insomnia based on DSM-IV criteria, and willing to participate.
  • Exclusion Criteria: Patients with conditions like Alzheimer’s, Parkinson’s disease, sleep apnea, or those who are pregnant, lactating, or have needle phobia.

• Intervention:

  • Study Group: Acupuncture at Ex-8 and Ex-9 for 30 minutes, four days a week, for four weeks.
  • Control Group: Sham acupuncture for the same duration and frequency.

• Primary Outcome: Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which assesses various aspects of sleep such as duration, latency, efficiency, and disturbances.

• Secondary Outcome: HRV will be assessed to evaluate changes in autonomic nervous system dynamics. HRV will be measured using the BIOPAC MP160 system and analyzed using Kubios HRV software.

Data Analysis:

• Statistical analysis will be conducted using SPSS software.
• Descriptive statistics will summarize the data, and inferential statistics (e.g., paired t-tests, ANOVA) will be used to compare pre- and post-treatment outcomes for both groups.

Ethical Considerations: Ethical approval will be obtained from the Institutional Ethics Committee, and all participants will provide informed consent before participating in the study. Participants will also be free to withdraw from the study at any point.

Expected Outcomes: This study aims to determine whether acupuncture at Ex-8 and Ex-9 can significantly improve sleep quality and modulate HRV in insomnia patients. It will also contribute to the growing body of evidence on acupuncture as a non-pharmacological treatment for insomnia. If successful, acupuncture could provide an alternative therapeutic approach for individuals suffering from sleep disorders.