Status:
COMPLETED
Study of the Effect of an Elastic Compression Medical Device, on Water Balance Change in Healthy Subjects
Lead Sponsor:
Laboratoires Innothera
Collaborating Sponsors:
Biotrial
Conditions:
Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS)
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by the occurrence of abnormally frequent episodes of interrupted ventilation (apnea) or significant reduction of ventilation (hypopne...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male subject aged 40 years old or more.
- Subject with a body mass index (BMI) between 18.5 and 30 kg/m².
- Healthy subject, registered in the French biomedical research volunteer national file.
- Subject for whom both lower limb measurements correspond to the size grid of the IMD used.
- Subject agreeing to abstain from alcohol intake from 48 hours before P1D-2, during all hospitalization periods and during the outpatient period.
- Subject accepting to proceed with a COVID-19 test at the time of each inpatient period, and for whom the result is negative
- Subject accepting to protect himself in an appropriate way to avoid COVID-19 infection during the outpatient period.
- Subject practicing under 5 hours of intense physical activity per week, on average, in the 4 weeks preceding the screening visit (e.g. no marathon training or military training).
- Subject agreeing to abstain from any strenuous activity, especially sports, from the screening visit to the end of clinical investigation (including during the outpatient period).
- Subject accepting the constraints of the clinical investigation.
- Subject being available for the duration of the clinical investigation.
- Subject who has signed the informed consent form (ICF) after being adequately informed and receiving the information sheet.
- Subject affiliated with the French social security system or receiving benefits of that type.
- Exclusion Criteria (non-inclusion criteria):
- Subject who is a smoker or a former smoker who stopped smoking less than 6 months ago.
- Subject following a salt-free diet.
- Subject following or planning to follow either a slimming diet or any specific diet that could not be followed during hospitalization.
- Subject having a temperature \> 38.0°C at screening or in the morning of D-2 and D1 of the first period (P1).
- Subject having, upon clinical examination, an abnormal systolic blood pressure (SBP), diastolic blood pressure (DBP) or heart rate (HR) judged clinically significant by the Investigator.
- Subject having an intestinal transit disorder that disrupts hydroelectric balance.
- Alcohol-dependent subject or subject with a positive alcohol breath test.
- Subject having a localized or general edema (a simple evening edema of the legs or ankles is accepted for inclusion).
- Subject suffering from insulin-dependent or uncontrolled diabetes (controlled diabetes is accepted).
- Subject with a serious, stabilized, or progressive illness (as judged by the Investigator).
- Subject with hypertension or heart failure.
- Subject with known renal function disorders.
- Subject with known liver failure.
- Subject with venous insufficiency of clinical class C3, C4, C5 or C6 according to the Clinical / Etiological / Anatomical / Pathophysiological (CEAP) classification.
- Subject having a medical background of deep and superficial vein thrombosis.
- Subject following long-term therapy with diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, nutritional supplements or opiates.
- Subject having, upon questioning or clinical examination, advanced peripheral neuropathy, skin infections, eczematous dermatitis, or weeping skin disorder of the legs.
- Subject with a medical contraindication to compression therapy according to the interview or clinical examination: phlegmatia coerulea dolens, septic thrombosis, intolerance to the IMD, allergic reaction to any component, arteritis obliterans of lower limbs, advanced diabetic microangiopathy.
- Subject with active implants, such as a pacemaker or artificial heart type, and non-active implants, for example a hip prosthesis (dental implants are authorized).
- Subject who is participating in another clinical trial or who is in the exclusion period from a previous study/clinical investigation.
- Person deprived of freedom by judicial or administrative decision, or a person hospitalized without his consent.
- Subject of legal age who is protected by law or under guardianship.
- Subject with a current mental or psychiatric disorder or a history of mental or psychiatric disorder, or any other factor limiting the collection of informed consent.
- Person who works for the CRO or for Laboratoires Innothera, or has a dependent relationship with these entities.
Exclusion
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04911725
Start Date
March 23 2021
End Date
May 24 2021
Last Update
June 7 2021
Active Locations (1)
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1
Biotrial
Rennes, France, 35042