Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy (LYMPHOS)
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|ClinicalTrials.gov Identifier: NCT02979184|
Recruitment Status : Active, not recruiting
First Posted : December 1, 2016
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema Obstructive Sleep Apnea Syndrome||Other: Intensive decongestive physiotherapy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevalence of Obstructive Sleep Apnea Syndrom in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||January 2019|
Intensive decongestive physiotherapy
2 weeks of intensive decongestive physiotherapy
Other: Intensive decongestive physiotherapy
2 weeks of intensive decongestive physiotherapy
- 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
- 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.
- 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)
- 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
- 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
- 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
- Correlation between BMI (Body Mass Index) and apnea/hypopnea index. [ Time Frame: 1 year ]BMI (kg/m^2)before and after rehabilitation
- Correlation between perimeter of the neck and apnea/hypopnea index [ Time Frame: 1 year ]Neck circumference (cm) before and after rehabilitation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979184
|Grenoble, France, 38043|
|Principal Investigator:||Béatrice VILLEMUR, PhD||University Hospital, Grenoble|