Clinical trial NCT02559427: SPA Therapy in the Treatment of Sleep Apnea Syndrome
Official title: Impact of 3-week SPA Therapy on Sleep Apnea in Patients With Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Chronic Venous Insufficiency
Keywords: sleep apnea
Venous Insufficiency
SPA treatment
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: Floralis
name: University Hospital, Grenoble
First posted: 2015-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).

Detailed description: Obstructive Sleep Apnea Syndrome (OSAS), characterized by repetitive episodes of partial or complete upper airway (UA) obstruction, is highly prevalent in the general population (2% in women, 4% in men). OSAS is associated with hypersomnolence and it increases the risk of cardiovascular morbidity and mortality. Its pathogenesis is largely multifactorial. In patients with chronic venous insufficiency, fluid retention contributes to this pathogenesis: during the day, fluid accumulates in the legs due to gravity ; during sleep in recumbent position, this accumulated fluid redistributes rostrally in the neck and causes upper airway narrowing and predisposes to OSAS.

The hypothesis is that a comprehensive treatment program for chronic venous insufficiency (SPA therapy) would reduce sleep apnea in patients with chronic venous insufficiency and concomitant sleep apnea Syndrome.

The objective is to assess the efficacy of a 3-week SPA therapy on attenuation of sleep apnea in this population of patients.

Eligibility criteria: Inclusion Criteria:

* Patient with Chronic Venous Insufficiency with oedema (CEAP clinical classes C3 to C5) and concomitant Sleep Apnea Syndrome (AHI \> 15 events/hour)
* Patient in stable state (no change in medical treatment and no hospitalization for respiratory, cardiac or metabolic event in the 2 months preceding inclusion)
* Patient available for a program of 3-week SPA Therapy

Exclusion Criteria:

* Patient with no social insurance
* Pregnant and nursing woman
* Patient detained by judicial order
* Patient with contra-indication to SPA therapy
* Patient with chronic venous insufficiency \< CEAP C3 or CEAP C6
* Patient already treated by class IV compression stockings for severe veinolymphatic insufficiency
* Patient already treated for sleep apnea
* Patient who have already benefited of SPA therapy (any type) within 9 months before the enrollment
* Patient with severe comorbidities
* Patient who could not respect the constraints related to the study

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 4.5 months
Secondary outcomes:
measure: Specific Quality of life
timeFrame: 4.5 months
measure: Global Quality of life
timeFrame: 4.5 months
measure: severity of sleep apnea
timeFrame: 4.5 months
measure: Nocturnal hypoxemia
timeFrame: 4.5 months
measure: Clinically significant improvement of OSAS
timeFrame: 4.5 months
measure: Sleep duration
timeFrame: 4.5 months
measure: Quality of Sleep
timeFrame: 4.5 months
measure: Daytime sleepiness
timeFrame: 4.5 months
measure: Variation of interstitial fluid
timeFrame: 4.5 months
measure: Long term efficacy
timeFrame: 1 year
measure: Venous insufficiency classification
timeFrame: 1 year
measure: Venous insufficiency variation
timeFrame: 1 year
measure: Venous insufficiency examination
timeFrame: 1 year
measure: long term effect of the SPA treatment on primary outcome
timeFrame: 1 year
measure: long term effect of the SPA treatment on specific quality of life
timeFrame: 1 year
measure: long term effect of the SPA treatment on global quality of life
timeFrame: 1 year
measure: long term effect of the SPA treatment on venous insufficiency
timeFrame: 1 year
measure: long term effect of the SPA treatment on specific treatment of OSAS
timeFrame: 1 year
measure: benefit for patients with first SPA treatment
timeFrame: 4.5 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Medical pratice (angiology)
city: Bourgoin Jallieu
country: France
facility: Medical practice (angiology)
city: Castelnau Le Lez
country: France
facility: Medical practice (angiology)
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Grenoble
country: France
facility: Medical pratice (angiology)
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Montpellier
country: France
facility: Clinic Beau Soleil
city: Tarbes
country: France
facility: Medical pratice (angiology)
city: Valence
country: France
facility: Medical practice (angiology)
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Louis PEPIN, MD
role: PRINCIPAL_INVESTIGATOR
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