Clinical Trials Directory

Trials / Completed

CompletedNCT04917094

Effectiveness of Compression Stocking on Overnight Fluid Shift in Obstructive Sleep Apnoea Patients

Effectiveness of Compression Stocking on Overnight Fluid Shift in Obstructive Sleep Apnea Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Khoo Teck Puat Hospital · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Overnight rostral fluid shift is one of the contributing factors for worsening obstructive sleep apnoea (OSA). Fluid shift has been recognized to play a role in the pathophysiology of sleep apnoea. Previous studies shown that fluid from the leg redistributes to the neck at night increases the neck circumference, hence indicating fluid accumulation in the neck. OSA patients are more susceptible to developing upper airway narrowing in response to fluid shift from the leg to the head and neck region. Previous studies were mainly done on Caucasian patients. The pathophysiology of OSA in Caucasian patients and Asian patients are different but both suffer a similar degree of OSA. The investigators would like to investigate if reducing leg swelling by a simple non-invasive intervention of wearing compression stocking during the day can attenuate sleep apnoea, and whether compression stocking is generally acceptable and well-tolerated among the general OSA population in Asia.

Conditions

Interventions

TypeNameDescription
DEVICECompression stockingA below-the-knee compression stock will be worn daily for 2 weeks from waking up to before sleep. Bioelectrical impedance will be performed before and 2 weeks after wearing the stocking to assess the total body water content. Measuring the calf and neck circumference will be done before and after wearing the compression stocking. After 2 weeks, the patient will return back to the clinic for calf and neck circumference measurement. Sleep test will be done the night before and 2 weeks after wearing the compression stocking. Oxygen Desaturation Index(ODI) will be assessed through a level 4 home sleep apnea testing device. Patients recruited will have mild excessive to severe excessive daytime sleepiness and/or STOP-Bang score of 3 or more, with underlying conditions such as type II diabetes and hypertensive patients using the Epworth sleepiness scale. Epworth sleepiness scale will be assessed again 2 weeks after to assess for increase sleep efficiency.

Timeline

Start date
2021-08-28
Primary completion
2022-11-12
Completion
2022-12-27
First posted
2021-06-08
Last updated
2023-04-10

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT04917094. Inclusion in this directory is not an endorsement.