Back to results

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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Compression stocking

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Khoo Teck Puat Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Below the knee compression stocking

Arm Description

Outcomes

Primary Outcome Measures

Compression stocking improves ODI of OSA patients

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04917094

First Posted

May 31, 2021

Last Updated

April 6, 2023

Sponsor

Khoo Teck Puat Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04917094

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

August 28, 2021 (Actual)

Primary Completion Date

November 12, 2022 (Actual)

Study Completion Date

December 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Khoo Teck Puat Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Below the knee compression stocking

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Compression stocking

Intervention Description

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 Outcome Measure Information:

Title

Compression stocking improves ODI of OSA patients

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edwin Seet

Organizational Affiliation

Khoo Teck Puat Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Khoo Teck Puat Hospital

City

Singapore

ZIP/Postal Code

768828

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21060007

Citation

Friedman O, Bradley TD, Chan CT, Parkes R, Logan AG. Relationship between overnight rostral fluid shift and obstructive sleep apnea in drug-resistant hypertension. Hypertension. 2010 Dec;56(6):1077-82. doi: 10.1161/HYPERTENSIONAHA.110.154427. Epub 2010 Nov 8.

Results Reference

result

PubMed Identifier

25761667

Citation

Gonzaga C, Bertolami A, Bertolami M, Amodeo C, Calhoun D. Obstructive sleep apnea, hypertension and cardiovascular diseases. J Hum Hypertens. 2015 Dec;29(12):705-12. doi: 10.1038/jhh.2015.15. Epub 2015 Mar 12.

Results Reference

result

PubMed Identifier

30177246

Citation

Perger E, Jutant EM, Redolfi S. Targeting volume overload and overnight rostral fluid shift: A new perspective to treat sleep apnea. Sleep Med Rev. 2018 Dec;42:160-170. doi: 10.1016/j.smrv.2018.07.008. Epub 2018 Aug 4.

Results Reference

result

PubMed Identifier

28527878

Citation

Reutrakul S, Mokhlesi B. Obstructive Sleep Apnea and Diabetes: A State of the Art Review. Chest. 2017 Nov;152(5):1070-1086. doi: 10.1016/j.chest.2017.05.009. Epub 2017 May 17.

Results Reference

result

PubMed Identifier

29404327

Citation

da Silva BC, Kasai T, Coelho FM, Zatz R, Elias RM. Fluid Redistribution in Sleep Apnea: Therapeutic Implications in Edematous States. Front Med (Lausanne). 2018 Jan 22;4:256. doi: 10.3389/fmed.2017.00256. eCollection 2017.

Results Reference

result

PubMed Identifier

25406274

Citation

White LH, Lyons OD, Yadollahi A, Ryan CM, Bradley TD. Night-to-night variability in obstructive sleep apnea severity: relationship to overnight rostral fluid shift. J Clin Sleep Med. 2015 Jan 15;11(2):149-56. doi: 10.5664/jcsm.4462.

Results Reference

result

PubMed Identifier

25620198

Citation

White LH, Lyons OD, Yadollahi A, Ryan CM, Bradley TD. Effect of below-the-knee compression stockings on severity of obstructive sleep apnea. Sleep Med. 2015 Feb;16(2):258-64. doi: 10.1016/j.sleep.2014.12.005. Epub 2014 Dec 18.

Results Reference

result

PubMed Identifier

23230237

Citation

White LH, Bradley TD. Role of nocturnal rostral fluid shift in the pathogenesis of obstructive and central sleep apnoea. J Physiol. 2013 Mar 1;591(5):1179-93. doi: 10.1113/jphysiol.2012.245159. Epub 2012 Dec 10.

Results Reference

result

PubMed Identifier

21220055

Citation

Redolfi S, Arnulf I, Pottier M, Bradley TD, Similowski T. Effects of venous compression of the legs on overnight rostral fluid shift and obstructive sleep apnea. Respir Physiol Neurobiol. 2011 Mar 15;175(3):390-3. doi: 10.1016/j.resp.2011.01.001. Epub 2011 Jan 8.

Results Reference

result

PubMed Identifier

21836140

Citation

Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.

Results Reference

result

Links:

URL

https://www.frontiersin.org/articles/10.3389/fmed.2017.00057/full

Description

Impact of Compression Stockings vs. Continuous Positive Airway Pressure on Overnight Fluid Shift and Obstructive Sleep Apnea among Patients on Hemodialysis

URL

https://academic.oup.com/ajh/article/31/8/857/4997027

Description

Sleep Disorders, Including Sleep Apnea and Hypertension

Learn more about this trial

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

We'll reach out to this number within 24 hrs