MOdification of Fluid Distribution In 90 Minutes

Obstructive Sleep Apnea Clinical Trial

Official title:

MOdification of Fluid Distribution In 90 Minutes : Pilot Study - MORFE 90

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05786248
• Other study ID #: MORFE90
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 2, 2024

Study information

• Verified date: March 2023
• Source: Poitiers University Hospital
• Contact: Vanessa BIRONNEAU
• Phone: 0549444444
• Email: vanessa.bironneau[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 liberty´ by a judicial or administrative decision, persons staying in a health or social institution and adults under legal protection, persons in emergency situations.

Related Conditions & MeSH terms

• Fluid Retention
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Other:
• Impedancemetry
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	90 minutes