Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy (LYMPHOS)
Primary Purpose
Lymphedema, Obstructive Sleep Apnea Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intensive decongestive physiotherapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphedema focused on measuring Lymphedema, Obstructive Sleep Apnea , Intensive Decongestive Physiotherapy
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.
Sites / Locations
- CHUGA
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intensive decongestive physiotherapy
Arm Description
2 weeks of intensive decongestive physiotherapy
Outcomes
Primary Outcome Measures
Prevalence of obstructive sleep apnea syndrom in patients with lymphedema, admitted for intensive decongestive physiotherapy.
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
Secondary Outcome Measures
Effect of intensive decongestive physiotherapy on the severity of the obstructive sleep apnea syndrom of patients with apnea/hypopnea index ≥ 5
Apnea/hypopnea index (AHI / h) before and after intensive decongestive physiotherapy.
Evolution of clinical signs associated with sleep apnea after rehabilitation
Clinical signs associated with sleep apnea: snoring, feeling of suffocation or oppression during sleep, non-restorative sleep, daytime fatigue, concentration difficulties, nocturia (clinical questionnaire)
Correlation between the volume of lymphedema of the suffering limb and the apnea/hypopnea index.
Measurement of limb perimeters (volumetry) before and after rehabilitation
Correlation between sleepiness measured by the Epworth scale before and after therapy, and the change in volume of lymphedema.
Score of the Epworth sleepiness scale before and after rehabilitation
Correlation between the quality of life as measured by the Medical Outcome Study Short Form questionnaire before and after rehabilitation, and apnea/hypopnea index.
Score in the MOS-SF-36 questionnaire before and after rehabilitation
Correlation between BMI (Body Mass Index) and apnea/hypopnea index.
BMI (kg/m^2)before and after rehabilitation
Correlation between perimeter of the neck and apnea/hypopnea index
Neck circumference (cm) before and after rehabilitation
Full Information
NCT ID
NCT02979184
First Posted
November 22, 2016
Last Updated
April 17, 2018
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02979184
Brief Title
Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy
Acronym
LYMPHOS
Official Title
Prevalence of Obstructive Sleep Apnea Syndrom in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Obstructive Sleep Apnea Syndrome
Keywords
Lymphedema, Obstructive Sleep Apnea , Intensive Decongestive Physiotherapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive decongestive physiotherapy
Arm Type
Other
Arm Description
2 weeks of intensive decongestive physiotherapy
Intervention Type
Other
Intervention Name(s)
Intensive decongestive physiotherapy
Intervention Description
2 weeks of intensive decongestive physiotherapy
Primary Outcome Measure Information:
Title
Prevalence of obstructive sleep apnea syndrom in patients with lymphedema, admitted for intensive decongestive physiotherapy.
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effect of intensive decongestive physiotherapy on the severity of the obstructive sleep apnea syndrom of patients with apnea/hypopnea index ≥ 5
Description
Apnea/hypopnea index (AHI / h) before and after intensive decongestive physiotherapy.
Time Frame
1 year
Title
Evolution of clinical signs associated with sleep apnea after rehabilitation
Description
Clinical signs associated with sleep apnea: snoring, feeling of suffocation or oppression during sleep, non-restorative sleep, daytime fatigue, concentration difficulties, nocturia (clinical questionnaire)
Time Frame
1 year
Title
Correlation between the volume of lymphedema of the suffering limb and the apnea/hypopnea index.
Description
Measurement of limb perimeters (volumetry) before and after rehabilitation
Time Frame
1 year
Title
Correlation between sleepiness measured by the Epworth scale before and after therapy, and the change in volume of lymphedema.
Description
Score of the Epworth sleepiness scale before and after rehabilitation
Time Frame
1 year
Title
Correlation between the quality of life as measured by the Medical Outcome Study Short Form questionnaire before and after rehabilitation, and apnea/hypopnea index.
Description
Score in the MOS-SF-36 questionnaire before and after rehabilitation
Time Frame
1 year
Title
Correlation between BMI (Body Mass Index) and apnea/hypopnea index.
Description
BMI (kg/m^2)before and after rehabilitation
Time Frame
1 year
Title
Correlation between perimeter of the neck and apnea/hypopnea index
Description
Neck circumference (cm) before and after rehabilitation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béatrice VILLEMUR, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUGA
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31636050
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.
Results Reference
derived
Learn more about this trial
Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy
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