Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy

Lymphedema Clinical Trial

— LYMPHOS  

Official title:

Prevalence of Obstructive Sleep Apnea Syndrom in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02979184
• Other study ID #: 38RC16.204
• Status: Active, not recruiting
• Phase: N/A
• First received: November 22, 2016
• Last updated: April 17, 2018
• Start date: November 2016
• Est. completion date: January 2019

Study information

• Verified date: April 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: January 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Lymphedema
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Intensive decongestive physiotherapy
2 weeks of intensive decongestive physiotherapy

Locations

Country	Name	City	State
France	CHUGA	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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.	1 year
Secondary	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)	1 year
Secondary	Correlation between the volume of lymphedema of the suffering limb and the apnea/hypopnea index.	Measurement of limb perimeters (volumetry) before and after rehabilitation	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	Correlation between BMI (Body Mass Index) and apnea/hypopnea index.	BMI (kg/m^2)before and after rehabilitation	1 year
Secondary	Correlation between perimeter of the neck and apnea/hypopnea index	Neck circumference (cm) before and after rehabilitation	1 year