Sleep Disorders Trial, Recruiting NCT06912334 Sponsor: National and Kapodistrian University of Athens Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06912334
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a woman between 18 and 79 years old
  • You have been diagnosed with Fibromyalgia using the ACR 2016 guidelines (confirm with trial site)
  • You have had moderate to severe pain (rated above 4 out of 10) for more than 6 months
  • You are able to understand the study instructions and follow along with the experiments
  • You are able to read and understand information shown on the device's screen
  • You are able to adjust the device's settings and tell the team how it feels (e.g. tingling, pulsating, or painful)
  • You are able to use the device for 30 minutes every day as recommended
  • The ear piece that comes with the device fits your ear
  • You have a physical or mental disability but can still give feedback about how the device feels, either by using it yourself or with the help of a caregiver

Who may not be able to join:

  • You have an irregular heartbeat or heart rhythm problem
  • You are pregnant
  • You have a serious mental health condition such as bipolar disorder or schizophrenia
  • You have had a previous injury to the vagus nerve (a major nerve running from the brain to the body)
  • You have scar tissue in the area where the device would be used that could interfere with the treatment (confirm with trial site)
  • You have an implanted medical device that is powered by electricity or magnetism, such as a pacemaker

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
National and Kapodistrian University of Athens
Registry
ClinicalTrials.gov
Start date
15 October 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇬🇷 Greece

Primary endpoints

Pain intensity and Fibromyalgia symptoms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov