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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khoo Teck Puat Hospital

Singapore, 768828

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 30 years old to 65 years old.
Either STOP-Bang score of ≥3 or Epworth sleepiness scale indicating mild excessive daytime sleepiness to severe excessive daytime sleepiness (11-24 points).
Has pre-existing diabetes mellitus and/or hypertension and is on medication.
Ability to provide informed consent.
Not working night shift.

Exclusion criteria

Significant arterial disease due to the risk of limb ischaemia and necrosis.
Not pregnant and not planning to get pregnant before the end of the study.
History of psychiatric disease.
Patient who are on wheelchair.
Patient who has cardiac failure and or stroke.
Patient who has end-stage renal failure. Estimated glomerular filtration rate <15ml/min/1.73m2 or on renal replacement therapy i.e. dialysis or renal transplant.
Patient who has liver disease.
Patient who are on pacemaker, and metal implants.
Patient who are on CPAP treatment for OSA.
Patient who are illiterate.
Medications which affect fluid balance or level of consciousness (e.g. diuretics, non- steroidal anti-inflammatory drugs (NSAIDS), corticosteroids, sedatives, opiates) at any time during the study.

Treatment and study plan

Compression stocking

Device

A 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.

Primary outcomes

Compression stocking improves ODI of OSA patients

Time frame: 2 weeks

Bioelectrical impedance analysis (BIA) readings performed before wearing the compression stocking and 2 weeks after wearing the compression stocking to assess the total body water, lower limb total water content (LLW), lower limbs extracellular water content (ecLLW), trunk total water content (TW), trunk extracellular water content (ecTW), neck fluid volume and leg fluid volume will be improved.

Calf and neck circumference measurements before wearing the compression stocking and 2 weeks after wearing the compression stocking will be improved.

Sleep test done to measure the Oxygen Desaturation Index (ODI) the night before wearing the compression stocking and 2 weeks before the final visit to the clinic will be improved.

Sponsors and collaborators

Lead sponsor

Khoo Teck Puat Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 8, 2021
Registry last updated: Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed