Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05786248
Other study ID # MORFE90
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A