NCT04911725

Study of the Effect of an Elastic Compression Medical Device, on Water Balance Change in Healthy Subjects

Study of the Effect of an Elastic Compression Medical Device (Prototype), on Water Balance Change in Healthy Subjects. Exploratory, Randomized, Open-label, Controlled and Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Laboratoires Innothera · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Accepted

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 (hypopnea) during sleep. It is linked to a repeated collapse of the upper airways during sleep. Episodes of apnea and hypopnea cause hypoxemia and micro-awakenings with a well-established impact on quality of life and daily activities. Physiologically, OSAHS can be aggravated when moving from a standing to a supine position through fluid shift from the lower limbs to the upper body, thereby modifying the opening of the upper airways. A decrease of the water balance by bilateral diurnal compression of the lower limbs (during daytime in standing position) may limit this nocturnal fluid shift (at night in supine position) and thus reduce the severity of OSAHS. Two comparative clinical trials \[Redolfi 2011; White 2015\] have shown a clinically modest reduction of sleep apnea (-36% and -27%, respectively), which was however statistically significant versus untreated control group (p = 0.002 and p = 0.04, respectively), when elastic compression medical devices of 20 to 30 mmHg were worn during the daytime. The hypothesis of fluid shift influence on OSAHS has been tested \[Berg 1993; Redolfi 2011; White 2015\], but the decrease of the water balance when the device is used remains to be quantified. The CVE101-15 exploratory clinical investigation sponsored by Laboratoires Innothera performed on healthy volunteers confirmed the hypothesis of a diuretic effect of elastic compression stockings applying a pressure of 33 mmHg at the ankle, worn for 13-14 hours during the daytime for 3 days, with a good safety profile of this device. Moreover, it enabled the identification of reliable parameters and the endpoints to be used to demonstrate a diuretic effect. Based on this information, there may be a real interest in conducting further investigations about the evolution of water balance beyond a 3-day period of elastic compression use in the daytime. Hence, the main objective of this clinical investigation is to compare precisely, under standardized test conditions, water balance changes in healthy subjects over 5 days with or without daytime use of the investigational medical device (IMD), an elastic compression device prototype specially designed for this study.

Conditions

• Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS)

Interventions

Type	Name	Description
DEVICE	Elastic Compression Prototype	Elastic Compression device - No medical, surgical or laboratory procedure is implied in the use of the IMD.

Timeline

• Start date: 2021-03-23
• Primary completion: 2021-05-24
• Completion: 2021-05-24
• First posted: 2021-06-03
• Last updated: 2021-06-07

Locations

1 site across 1 country: France