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Trial record 2 of 3 for:    22618924 [PUBMED-IDS]

SPA Therapy in the Treatment of Sleep Apnea Syndrome (THERMA-SAS)

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ClinicalTrials.gov Identifier: NCT02559427
Recruitment Status : Withdrawn (no patients randomized after more than one year sponsor decided to withdrawn the study.)
First Posted : September 24, 2015
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Floralis
University Hospital, Grenoble
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale

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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Chronic Venous Insufficiency Other: 3-week immediate SPA treatment Other: 3-week late SPA treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Immediate SPA treatment
3-week immediate SPA treatment (soon after randomization)
Other: 3-week immediate SPA treatment
a comprehensive program soon after randomization including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)
Other Name: Immediate SPA treatment

Sham Comparator: Late SPA treatment
3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit)
Other: 3-week late SPA treatment
a comprehensive program after 4.5 months, including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)
Other Name: Late SPA treatment




Primary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI) [ Time Frame: 4.5 months ]
    Variation in AHI according to the allocation group


Secondary Outcome Measures :
  1. Specific Quality of life [ Time Frame: 4.5 months ]
    Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency)

  2. Global Quality of life [ Time Frame: 4.5 months ]
    Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale)

  3. severity of sleep apnea [ Time Frame: 4.5 months ]
    Variation of AHI according to the severity of sleep apnea at inclusion. Moderate sleep apnea (AHI <30) vs Severe Sleep apnea (AHI >30) at inclusion

  4. Nocturnal hypoxemia [ Time Frame: 4.5 months ]
    Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90%

  5. Clinically significant improvement of OSAS [ Time Frame: 4.5 months ]
    Clinically significant improvement is defined with a reduction in AHI by 50% or more and a reduction in oxygen desaturation index by 50% or more

  6. Sleep duration [ Time Frame: 4.5 months ]
    Mean sleep duration is assessed by actigraphy over a period of 7 days.

  7. Quality of Sleep [ Time Frame: 4.5 months ]
    Quality of sleep is assessed by Quebec Quality of life Questionnaire

  8. Daytime sleepiness [ Time Frame: 4.5 months ]
    Sleepiness is assessed by Epworth sleepiness scale

  9. Variation of interstitial fluid [ Time Frame: 4.5 months ]
    bioimpedance is used to measure interstitial fluid

  10. Long term efficacy [ Time Frame: 1 year ]
    Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP

  11. Venous insufficiency classification [ Time Frame: 1 year ]
    Variation of venous insufficiency is assessed by CEAP classification

  12. Venous insufficiency variation [ Time Frame: 1 year ]
    Variation of venous insufficiency is assessed by Villalta score

  13. Venous insufficiency examination [ Time Frame: 1 year ]
    Variation of venous insufficiency is assessed by leg circumferences

  14. long term effect of the SPA treatment on primary outcome [ Time Frame: 1 year ]
    confirmation of the long term effect of the SPA treatment at 1 year for the control group. Primary outcome evolution between 4.5 months and 12 months (evolution of AHI)

  15. long term effect of the SPA treatment on specific quality of life [ Time Frame: 1 year ]
    confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of specific quality of life with CIVIQ 20 scale

  16. long term effect of the SPA treatment on global quality of life [ Time Frame: 1 year ]
    confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of global quality of life with EUROQUOL Scale

  17. long term effect of the SPA treatment on venous insufficiency [ Time Frame: 1 year ]
    confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of venous insufficiency

  18. long term effect of the SPA treatment on specific treatment of OSAS [ Time Frame: 1 year ]
    confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months. The long term effect will be confirmed if patients did not require a specific treatment of OSAS (for example CPAP (Continuous Positive Airway Pressure).

  19. benefit for patients with first SPA treatment [ Time Frame: 4.5 months ]
    stratification at randomization (first SPA treatment or not) to evaluate a higher benefit (variation of Apnea-Hypopnea Index (AHI)) for patients with first SPA treatment. Comparison of patients with first SPA treatment or not on primary outcome according to the allocation group.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02559427


Locations
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France
Medical pratice (angiology)
Annecy, France
Medical practice (angiology)
Bourgoin Jallieu, France
Medical practice (angiology)
Castelnau Le Lez, France
University Hospital Grenoble
Grenoble, France, 38000
Medical pratice (angiology)
Grenoble, France
University Hospital Grenoble
Grenoble, France
Clinic Beau Soleil
Montpellier, France
Medical pratice (angiology)
Tarbes, France
Medical practice (angiology)
Valence, France
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Floralis
University Hospital, Grenoble
Investigators
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Principal Investigator: Jean Louis PEPIN, MD University Hospital, Grenoble

Publications:

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Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT02559427     History of Changes
Other Study ID Numbers: THERMA SAS
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Keywords provided by Association Francaise pour la Recherche Thermale:
sleep apnea
Venous Insufficiency
SPA treatment
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Venous Insufficiency
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases