Meta description: A not yet recruiting device trial tests remote ischemic adaptation for insomnia after stroke, signaling regulatory attention for a two arm ischemic preconditioning system.
Researchers at the Second Affiliated Hospital of Nanchang University are evaluating remote ischemic adaptation using intermittent pressure stimulation to treat insomnia following stroke. The study is registered on ClinicalTrials.gov under NCT07401784. The trial compares an active Automatic ischemic preconditioning therapeutic apparatus with a Sham Ischemic Preconditioning Device to assess efficacy and safety. The patient population includes individuals with cerebral apoplexy, cerebrovascular disease and related mood disorders. The sponsor is the Second Affiliated Hospital of Nanchang University. The entry date for this update is February 11, 2026. The trial status is Not yet recruiting. This report presents what is known from the source text and what stakeholders should monitor as the trial progresses. External reference is provided to the ClinicalTrials.gov record.
In this article What is the trial design? | What devices are used and how are they employed? | Who sponsors and what is the status? | What are the regulatory implications? | Who should follow? | What about safety and ethics?
How is the trial designed to evaluate efficacy and safety?
The source text indicates a two arm design with an active ischemic preconditioning device and a sham device. The aim is to evaluate feasibility, safety and potential efficacy signals for insomnia after stroke. The not yet recruiting status signals an early stage of development and a focus on device performance and safety language.
What devices are used and how are they employed?
The trial uses two devices: an Automatic ischemic preconditioning therapeutic apparatus as the active device and a Sham ischemic preconditioning device as the control. Both are described as delivering intermittent pressure stimulation. The trial targets insomnia after stroke in patients with cerebral vascular disease. No results are reported in the source text.
Who sponsors and what is the status?
Sponsor: Second Affiliated Hospital of Nanchang University. Status: Not yet recruiting. The ClinicalTrials.gov page provides the official status and registry details and the entry identifies cerebral apoplexy, depression anxiety disorder and cerebrovascular disease as conditions under study.
What are the regulatory implications for device developers and regulators?
This is an early stage device evaluation. Regulators would expect precise indication statements, clear safety endpoints and documented risk management in any future submission. The discussion here reflects the source text and not formal regulatory guidance. Internal links for context include Ischemic preconditioning devices regulatory path and Device trials for post stroke insomnia.
Who should watch this trial and why?
Clinicians who treat sleep disorders after stroke, researchers in device trials, quality and regulatory teams, and the sponsor should monitor this trial. The two arm design with a sham comparator helps to identify safety signals ahead of efficacy conclusions, and updates should come from the ClinicalTrials.gov record.
What about safety and ethics?
The design includes a active and a sham comparator to support safety evaluation. The source text notes a focus on safety alongside feasibility for a device based approach to insomnia after stroke. Ethics oversight would align with standard clinical trial practice for device studies.
External link to the official trial record is provided for reference and oversight.
Conclusion
The trial represents an early step in evaluating remote ischemic adaptation for sleep disturbance after stroke. Regulatory and clinical stakeholders should monitor updates on the ClinicalTrials.gov page as results emerge and consider the path this device may take in future submissions.
Disclaimer: This article is for professionals. It is not legal advice and does not constitute regulatory guidance. Consult the official regulatory sources for formal decisions.