Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy

NCT ID: NCT02979184

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-01-31

Brief Summary

Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a decrease in the amount of liquid of the affected limb, with movement of the intracellular liquid towards the trunk and the neck then into the jugular-subclavian confluence, the superior vena cava and right atrium without modification of extracellular fluid. No study have evaluated the prevalence of sleep apnea syndrome in this population and the effect of this treatment on sleep apnea syndrome.

Detailed Description

Lymphedema is the result of an intra-tissue fluid accumulation by failure of the lymphatic system to absorb the excess fluid from the veinulo-capillary circulation. Lymphedema can be primitive with aplasia or hypoplasia of the lymphatic vessels or secondary by destruction of the lymphatic structures.

We define three stages of severity of lymphedema:

• Stage I: increase of volume which is mitigate when the limb is raised
• Stage II: the elevation does not reduce anymore the volume and the oedema is still compressible. It produces skin changes such as fibrosis, rendered by the sign of Stemmer.
• Stage III: elephantiasis with disappearance of the compressible nature of edema, appearance of trophic skin disorders (papillomas, vesicles) and nail disorders.

The first-line treatment of lymphedema corresponds to a physical therapy by decongestive physiotherapy. This intensive rehabilitation includes sessions of manual lymphatic drainages or pressure therapy sessions followed by the application of inelastic multilayer bandages, muscle exercises under bandages, skin care and pedicure for lymphedema of the lower limbs.

Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a decrease in the amount of liquid of the affected limb, with movement of the intracellular liquid towards the trunk and the neck then into the jugular-subclavian confluence, the superior vena cava and right atrium without modification of extracellular fluid. No study have evaluated the prevalence of sleep apnea syndrome in this population and the effect of this treatment on sleep apnea syndrome.

The interest of this study is to evaluate the prevalence of sleep apnea syndrome at patients suffering from lymphedema and the effect of intensive decongestive physiotherapy on the syndrome of sleep apnea by modification of the fluid redistribution.

Conditions

Lymphedema; Obstructive Sleep Apnea Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intensive decongestive physiotherapy

2 weeks of intensive decongestive physiotherapy

Group Type: OTHER

Intensive decongestive physiotherapy

Intervention Type: OTHER

2 weeks of intensive decongestive physiotherapy

Interventions

Intensive decongestive physiotherapy

2 weeks of intensive decongestive physiotherapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Lymphedema of one or several limbs (with difference of more than 2 cms compared with the collateral limb) without contraindication in an intensive decongestive physiotherapy.
• Patient member to the social security or beneficiary of such a regime.
• Patient having signed the informed consent for participation to the study

Exclusion Criteria

• Medical Contraindication in an intensive decongestive physiotherapy : Acute infectious episode (Erysipelas, lymphangitis), acute venous thrombosis, uncontrolled heart failure or hypertension, acute renal failure, obstruction of the superior vena cava, evolutionary untreated malignant tumor, peripheral arterial disease with ankle brachial indices w< 0,5, evolved diabetic angiopathy, septic thrombosis, popliteal aneurysm.
• Patients deprived of freedom by court or admninistrative order. Person being the object of a legal protective measure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice VILLEMUR, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

CHUGA

Grenoble, , France

Countries

France

References

Roux C, Villemur B, Giovannoni B, Koeyemelk L, Mendelson M, Benmerad M, Joyeux-Faure M, Tamisier R, Pepin JL. Prevalence of obstructive sleep apnea syndrome in patients with lymphedema referred for complete decongestive therapy. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):137-142. doi: 10.1016/j.jvsv.2019.07.007. Epub 2019 Oct 18.

Reference Type: DERIVED

PMID: 31636050 (View on PubMed)

Other Identifiers

38RC16.204

Identifier Type: -

Identifier Source: org_study_id