Clinical trial NCT02979184: Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy
Official title: Prevalence of Obstructive Sleep Apnea Syndrom in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Obstructive Sleep Apnea Syndrome
Keywords: Lymphedema, Obstructive Sleep Apnea , Intensive Decongestive Physiotherapy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Prevalence of obstructive sleep apnea syndrom in patients with lymphedema, admitted for intensive decongestive physiotherapy.
timeFrame: 1 year
Secondary outcomes:
measure: Effect of intensive decongestive physiotherapy on the severity of the obstructive sleep apnea syndrom of patients with apnea/hypopnea index ≥ 5
timeFrame: 1 year
measure: Evolution of clinical signs associated with sleep apnea after rehabilitation
timeFrame: 1 year
measure: Correlation between the volume of lymphedema of the suffering limb and the apnea/hypopnea index.
timeFrame: 1 year
measure: Correlation between sleepiness measured by the Epworth scale before and after therapy, and the change in volume of lymphedema.
timeFrame: 1 year
measure: Correlation between the quality of life as measured by the Medical Outcome Study Short Form questionnaire before and after rehabilitation, and apnea/hypopnea index.
timeFrame: 1 year
measure: Correlation between BMI (Body Mass Index) and apnea/hypopnea index.
timeFrame: 1 year
measure: Correlation between perimeter of the neck and apnea/hypopnea index
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHUGA
Study officials:
affiliation: University Hospital, Grenoble
name: Béatrice VILLEMUR, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.