Obstructive Sleep ApneaNCT04917094
Effectiveness of Compression Stocking on Overnight Fluid Shift in Obstructive Sleep Apnoea Patients
A study testing Compression stocking in people with Obstructive Sleep Apnea, run by Khoo Teck Puat Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Aug 2021to 27 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Compression Stocking on Overnight Fluid Shift in Obstructive Sleep Apnea 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Compression stocking
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stockingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Below the knee compression stocking | Experimental | Not described Receives: Device: Compression stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start28 Aug 2021
- Primary completion12 Nov 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edwin Seet, Principal investigator, Khoo Teck Puat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917094
- Sponsor's protocol ID
- 2021/00393
- Status last verified
- Dec 2022
- First submitted
- 31 May 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21060007Gonzaga 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.
PubMed 25761667Perger 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.
PubMed 30177246Reutrakul 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.
PubMed 28527878da 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.
PubMed 29404327White 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.
PubMed 25406274White 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.
PubMed 25620198White 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.
PubMed 23230237Redolfi 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.
PubMed 21220055Redolfi 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.
PubMed 21836140
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Compression Stocking on Overnight Fluid Shift in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT04917094
- Acronym / sponsor ID
- 2021/00393
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Below the knee compression stocking | Experimental | Device: Compression stocking |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression 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. | Device | Below the knee compression stocking |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Results publication: PubMed 21060007Friedman 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 publication: PubMed 25761667Gonzaga 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 publication: PubMed 30177246Perger 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 publication: PubMed 28527878Reutrakul 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 publication: PubMed 29404327da 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 publication: PubMed 25406274White 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 publication: PubMed 25620198White 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 publication: PubMed 23230237White 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 publication: PubMed 21220055Redolfi 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 publication: PubMed 21836140Redolfi 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.
- Impact of Compression Stockings vs. Continuous Positive Airway Pressure on Overnight Fluid Shift and Obstructive Sleep Apnea among Patients on HemodialysisLink provided by the sponsor.
- Night-to-night Variability in Obstructive Sleep Apnea Severity: Relationship to Overnight Rostral Fluid ShiftLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Seet principal investigator
Khoo Teck Puat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression stocking in people with Obstructive Sleep Apnea, run by Khoo Teck Puat Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compression stocking improves ODI of OSA patients (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917094, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023; AzTrials last refreshed its copy on 28 Oct 2026.