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

Primary Purpose

Obstructive Sleep Apnea Syndrome, Chronic Venous Insufficiency

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3-week immediate SPA treatment
3-week late SPA treatment
Sponsored by
Association Francaise pour la Recherche Thermale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring sleep apnea, Venous Insufficiency, SPA treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical pratice (angiology)
  • Medical practice (angiology)
  • Medical practice (angiology)
  • University Hospital Grenoble
  • Medical pratice (angiology)
  • University Hospital Grenoble
  • Clinic Beau Soleil
  • Medical pratice (angiology)
  • Medical practice (angiology)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Immediate SPA treatment

Late SPA treatment

Arm Description

3-week immediate SPA treatment (soon after randomization)

3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit)

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index (AHI)
Variation in AHI according to the allocation group

Secondary Outcome Measures

Specific Quality of life
Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency)
Global Quality of life
Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale)
severity of sleep apnea
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
Nocturnal hypoxemia
Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90%
Clinically significant improvement of OSAS
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
Sleep duration
Mean sleep duration is assessed by actigraphy over a period of 7 days.
Quality of Sleep
Quality of sleep is assessed by Quebec Quality of life Questionnaire
Daytime sleepiness
Sleepiness is assessed by Epworth sleepiness scale
Variation of interstitial fluid
bioimpedance is used to measure interstitial fluid
Long term efficacy
Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP
Venous insufficiency classification
Variation of venous insufficiency is assessed by CEAP classification
Venous insufficiency variation
Variation of venous insufficiency is assessed by Villalta score
Venous insufficiency examination
Variation of venous insufficiency is assessed by leg circumferences
long term effect of the SPA treatment on primary outcome
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)
long term effect of the SPA treatment on specific quality of life
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
long term effect of the SPA treatment on global quality of life
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
long term effect of the SPA treatment on venous insufficiency
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
long term effect of the SPA treatment on specific treatment of OSAS
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).
benefit for patients with first SPA treatment
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.

Full Information

First Posted
July 29, 2015
Last Updated
June 28, 2018
Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
Floralis, University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02559427
Brief Title
SPA Therapy in the Treatment of Sleep Apnea Syndrome
Acronym
THERMA-SAS
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
no patients randomized after more than one year sponsor decided to withdrawn the study.
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
Floralis, University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Chronic Venous Insufficiency
Keywords
sleep apnea, Venous Insufficiency, SPA treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate SPA treatment
Arm Type
Active Comparator
Arm Description
3-week immediate SPA treatment (soon after randomization)
Arm Title
Late SPA treatment
Arm Type
Sham Comparator
Arm Description
3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit)
Intervention Type
Other
Intervention Name(s)
3-week immediate SPA treatment
Other Intervention Name(s)
Immediate SPA treatment
Intervention Description
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...)
Intervention Type
Other
Intervention Name(s)
3-week late SPA treatment
Other Intervention Name(s)
Late SPA treatment
Intervention Description
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...)
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI)
Description
Variation in AHI according to the allocation group
Time Frame
4.5 months
Secondary Outcome Measure Information:
Title
Specific Quality of life
Description
Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency)
Time Frame
4.5 months
Title
Global Quality of life
Description
Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale)
Time Frame
4.5 months
Title
severity of sleep apnea
Description
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
Time Frame
4.5 months
Title
Nocturnal hypoxemia
Description
Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90%
Time Frame
4.5 months
Title
Clinically significant improvement of OSAS
Description
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
Time Frame
4.5 months
Title
Sleep duration
Description
Mean sleep duration is assessed by actigraphy over a period of 7 days.
Time Frame
4.5 months
Title
Quality of Sleep
Description
Quality of sleep is assessed by Quebec Quality of life Questionnaire
Time Frame
4.5 months
Title
Daytime sleepiness
Description
Sleepiness is assessed by Epworth sleepiness scale
Time Frame
4.5 months
Title
Variation of interstitial fluid
Description
bioimpedance is used to measure interstitial fluid
Time Frame
4.5 months
Title
Long term efficacy
Description
Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP
Time Frame
1 year
Title
Venous insufficiency classification
Description
Variation of venous insufficiency is assessed by CEAP classification
Time Frame
1 year
Title
Venous insufficiency variation
Description
Variation of venous insufficiency is assessed by Villalta score
Time Frame
1 year
Title
Venous insufficiency examination
Description
Variation of venous insufficiency is assessed by leg circumferences
Time Frame
1 year
Title
long term effect of the SPA treatment on primary outcome
Description
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)
Time Frame
1 year
Title
long term effect of the SPA treatment on specific quality of life
Description
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
Time Frame
1 year
Title
long term effect of the SPA treatment on global quality of life
Description
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
Time Frame
1 year
Title
long term effect of the SPA treatment on venous insufficiency
Description
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
Time Frame
1 year
Title
long term effect of the SPA treatment on specific treatment of OSAS
Description
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).
Time Frame
1 year
Title
benefit for patients with first SPA treatment
Description
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.
Time Frame
4.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis PEPIN, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical pratice (angiology)
City
Annecy
Country
France
Facility Name
Medical practice (angiology)
City
Bourgoin Jallieu
Country
France
Facility Name
Medical practice (angiology)
City
Castelnau Le Lez
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Medical pratice (angiology)
City
Grenoble
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
Country
France
Facility Name
Clinic Beau Soleil
City
Montpellier
Country
France
Facility Name
Medical pratice (angiology)
City
Tarbes
Country
France
Facility Name
Medical practice (angiology)
City
Valence
Country
France

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SPA Therapy in the Treatment of Sleep Apnea Syndrome

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