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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Lymphedema Obstructive Sleep Apnea Syndrome Other: Intensive decongestive physiotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intensive decongestive physiotherapy
2 weeks of intensive decongestive physiotherapy
Other: Intensive decongestive physiotherapy
2 weeks of intensive decongestive physiotherapy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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

  4. 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

  5. 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

  6. Correlation between BMI (Body Mass Index) and apnea/hypopnea index. [ Time Frame: 1 year ]
    BMI (kg/m^2)before and after rehabilitation

  7. Correlation between perimeter of the neck and apnea/hypopnea index [ Time Frame: 1 year ]
    Neck circumference (cm) before and after rehabilitation



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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France
CHUGA
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Béatrice VILLEMUR, PhD University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02979184     History of Changes
Other Study ID Numbers: 38RC16.204
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
Lymphedema, Obstructive Sleep Apnea , Intensive Decongestive Physiotherapy

Additional relevant MeSH terms:
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Lymphedema
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Lymphatic Diseases