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"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.

Not Applicable
Completed
Conditions
Sexual Satisfaction
Registration Number
NCT06304558
Lead Sponsor
Universidad Europea de Madrid
Brief Summary

The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.

As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results.

Detailed Description

Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus,. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs are covered through the sympathetic paravertebral ganglia and the sacral plexus.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Subjects from 18 to 65 years
  • Sexually active
  • Signed consent form
Exclusion Criteria
  • Diagnosed diseases.
  • Severe previous psychiatric conditions.
  • Medical contraindications that prevent the use of non-invasive neuromodulation therapy.
  • Having exercised in the hours prior to the NESA treatment.
  • Having consumed coffee or tobacco in the hours prior to the treatment.
  • Minors.
  • Individuals who have previously received any type of neuromodulation treatment.
  • Cancer.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Sexual satisfaction10 minutes

Questionnaire

Secondary Outcome Measures
NameTimeMethod
Sleep Quality10 minutes

Questionnaire

Blood Pressure (Sistolic and diastolic)5 minutes

Sfignomanometer

Heartbeats per minute5 minutes

We Cardio http://en.wecardio.com/3_1ourmachinepage.html

Stress levels10 minutes

Questionnaire

Trial Locations

Locations (1)

Universidad Europea de Madrod

🇪🇸

Villaviciosa de Odón, Spain

Universidad Europea de Madrod
🇪🇸Villaviciosa de Odón, Spain

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