Home Diseases and Conditions Insomnia

Insomnia

Last Updated:
Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound for this condition is being researched in clinical trials.

Focused Ultrasound Therapy 

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with insomnia. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated. A report by Shanghai International Medical Center using high intensity thermal ablation to treat this disease. Low intensity focused ultrasound directed to those recovering from opioid use disorder has aided in their recovery of normal sleep. A preclinical study has shown that stimulation can excite the local GABA pathway to override the simultaneous increase in the dopaminergic pathway. There is also some use of neuromodulation of the medial prefrontal cortex to aid in this treatment. There is no FDA or equivalent international regulatory approval for the use of this treatment, so we will continue to follow the clinical trials for the development of this technology.  

The primary options for treatment of insomnia include medication and with less often use of invasive surgery. For certain patients, focused ultrasound could provide a non-invasive alternative to conventional treatments.  

While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

Advantages 

  • Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  
  • Focused ultrasound can reach the desired target without damaging surrounding tissue. 
  • It can be repeated, if necessary. 

Clinical Trials 

A clinical trial in Egypt is using focused ultrasound to treat patients for insomnia.  

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/. 

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for insomnia is not yet approved by regulatory bodies or covered by medical insurance companies.  

Notable Papers 

Meads KL, Huettner S, Amata D, Johnson H, Devine JK, Warnakulasuriya S, Murphy KR, Good CH. Feasibility and acceptability of wearing a neuromodulation device at night in individuals in recovery from opioid use disorder. Front Psychiatry. 2024 Nov 29;15:1481795. doi: 10.3389/fpsyt.2024.1481795. eCollection 2024. PMID: 39676914  

Kim YG, Kim SE, Lee J, Hwang S, Yoo SS, Lee HW. Neuromodulation Using Transcranial Focused Ultrasound on the Bilateral Medial Prefrontal Cortex. J Clin Med. 2022 Jun 30;11(13):3809. doi: 10.3390/jcm11133809. PMID: 35807094  

Click here for additional references from PubMed.