- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02979184
Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy (LYMPHOS)
Prevalence of Obstructive Sleep Apnea Syndrom in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Grenoble, France, 38043
- CHUGA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intensive decongestive physiotherapy
2 weeks of intensive decongestive physiotherapy
|
2 weeks of intensive decongestive physiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of obstructive sleep apnea syndrom in patients with lymphedema, admitted for intensive decongestive physiotherapy.
Time Frame: 1 year
|
Apnea/hypopnea index (AHI /h) measured by Apnea-Link or antecedent of Obstructive sleep apnea syndrom already treated with CPAP (Continuous Positive Airway Pressure) ventilation
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of intensive decongestive physiotherapy on the severity of the obstructive sleep apnea syndrom of patients with apnea/hypopnea index ≥ 5
Time Frame: 1 year
|
Apnea/hypopnea index (AHI / h) before and after intensive decongestive physiotherapy.
|
1 year
|
Evolution of clinical signs associated with sleep apnea after rehabilitation
Time Frame: 1 year
|
Clinical signs associated with sleep apnea: snoring, feeling of suffocation or oppression during sleep, non-restorative sleep, daytime fatigue, concentration difficulties, nocturia (clinical questionnaire)
|
1 year
|
Correlation between the volume of lymphedema of the suffering limb and the apnea/hypopnea index.
Time Frame: 1 year
|
Measurement of limb perimeters (volumetry) before and after rehabilitation
|
1 year
|
Correlation between sleepiness measured by the Epworth scale before and after therapy, and the change in volume of lymphedema.
Time Frame: 1 year
|
Score of the Epworth sleepiness scale before and after rehabilitation
|
1 year
|
Correlation between the quality of life as measured by the Medical Outcome Study Short Form questionnaire before and after rehabilitation, and apnea/hypopnea index.
Time Frame: 1 year
|
Score in the MOS-SF-36 questionnaire before and after rehabilitation
|
1 year
|
Correlation between BMI (Body Mass Index) and apnea/hypopnea index.
Time Frame: 1 year
|
BMI (kg/m^2)before and after rehabilitation
|
1 year
|
Correlation between perimeter of the neck and apnea/hypopnea index
Time Frame: 1 year
|
Neck circumference (cm) before and after rehabilitation
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Béatrice VILLEMUR, PhD, University Hospital, Grenoble
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC16.204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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