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MOdification of Fluid Distribution In 90 Minutes

Primary Purpose

Obstructive Sleep Apnea, Fluid Retention

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Impedancemetry
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 18 years of age or older Patients requiring polysomnography at the regional sleep pathology center for suspected nocturnal breathing disorders Patients able to give their non-opposition Exclusion Criteria: The presence of metallic implants in the lower limbs or spine or implantable pacemakers because of possible interference with the impedance signals A history of amputation of both lower limbs Persons benefiting from reinforced protection, namely minors, persons deprived of libertý by a judicial or administrative decision, persons staying in a health or social institution and adults under legal protection, persons in emergency situations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Impedancemtry

    Arm Description

    measurement of fluid shift by impedancemetry, recording by polysomnography, measurement of neck, calf and ankle perimeters, at different times: 0 min (T0), 30min (T30), 90min (T90), and the next day on waking

    Outcomes

    Primary Outcome Measures

    To evaluate the agreement between impedancemetry measurements at T90 minutes and impedancemetry measurements after an overnight supine position in the assessment of Fluid-Shift.
    The criterion evaluated is the fluid volume redistributed between the lower limbs and the neck by impedancemetry between T0 and T90 minutes and between T0 and after one night of supine.The concordance criterion is the intraclass correlation coefficient (ICC).

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    March 14, 2023
    Sponsor
    Poitiers University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05786248
    Brief Title
    MOdification of Fluid Distribution In 90 Minutes
    Official Title
    MOdification of Fluid Distribution In 90 Minutes : Pilot Study - MORFE 90
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 2, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poitiers University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a cardiovascular risk factor due to intermittent hypoxia phenomena. Several etiological factors are involved in the pathogenesis of OSAS. Among them, the rostro-caudal displacement of fluid during dorsal decubitus has been highlighted. Under the effect of gravity, an accumulation of fluid is possible in the lower limbs, redistributing itself towards the upper parts of the body during the supine position. This phenomenon of fluid shift is usually evaluated by impedancemetry after a night in the supine position. However, some authors have shown that fluid shift occurs within 90 minutes after supine. Thus, in the perspective of future studies, in order to simplify the implementation of this evaluation and to reduce the time of hospitalization necessary for the subjects participating in the study, we would like to verify the correlation between the impedancemetry measurement at T 90 min and that obtained after one night of supine position. This is a single-center, prospective, open-label study at the Poitiers University Hospital. We will include 30 patients over 18 years of age admitted to the regional sleep pathology center for suspected nocturnal respiratory disorders to receive polysomnography and able to provide written consent.We excluded : patients younger than 18 years of age, A history of vascular surgery of the lower limbs such as varicose vein surgery, vascular bypass surgery, carcinological surgery with lymph node dissection, the presence of metallic implants in the lower limbs or spine or implantable cardiac devices, those not receiving Social Securitý or not receiving it through a third party, persons receiving enhanced protection, namely minors, and persons deprived of libertý by a judicial or administrative decision, persons staying in a health or social institution, and adults under legal protection.we will perform an impedance measurement at T0, T30, T90, and after overnight supine. Impedance measurement is performed using electrodes delivering a low intensity current of known frequency allowing the study of the liquid volume.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea, Fluid Retention

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Impedancemtry
    Arm Type
    Other
    Arm Description
    measurement of fluid shift by impedancemetry, recording by polysomnography, measurement of neck, calf and ankle perimeters, at different times: 0 min (T0), 30min (T30), 90min (T90), and the next day on waking
    Intervention Type
    Other
    Intervention Name(s)
    Impedancemetry
    Intervention Description
    the impedance measurement electrodes are placed on the lower limbs and neck. After the first measurement, the patients are invited to lie down. A new series of measurements will be performed at 30 (T30), 90 minutes (T90) and in the morning.
    Primary Outcome Measure Information:
    Title
    To evaluate the agreement between impedancemetry measurements at T90 minutes and impedancemetry measurements after an overnight supine position in the assessment of Fluid-Shift.
    Description
    The criterion evaluated is the fluid volume redistributed between the lower limbs and the neck by impedancemetry between T0 and T90 minutes and between T0 and after one night of supine.The concordance criterion is the intraclass correlation coefficient (ICC).
    Time Frame
    90 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years of age or older Patients requiring polysomnography at the regional sleep pathology center for suspected nocturnal breathing disorders Patients able to give their non-opposition Exclusion Criteria: The presence of metallic implants in the lower limbs or spine or implantable pacemakers because of possible interference with the impedance signals A history of amputation of both lower limbs Persons benefiting from reinforced protection, namely minors, persons deprived of libertý by a judicial or administrative decision, persons staying in a health or social institution and adults under legal protection, persons in emergency situations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vanessa BIRONNEAU
    Phone
    0549444444
    Email
    vanessa.bironneau@chu-poitiers.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nadia IMZI
    Phone
    0549444444
    Email
    nadia.imzi@chu-poitiers.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    MOdification of Fluid Distribution In 90 Minutes

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