Obstructive Sleep Apnea Syndrome Clinical Trial
— THERMA-SASOfficial 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
NCT number | NCT02559427 |
Other study ID # | THERMA SAS |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | March 2019 |
Verified date | June 2018 |
Source | Association Francaise pour la Recherche Thermale |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2019 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Medical pratice (angiology) | Annecy | |
France | Medical practice (angiology) | Bourgoin Jallieu | |
France | Medical practice (angiology) | Castelnau Le Lez | |
France | Medical pratice (angiology) | Grenoble | |
France | University Hospital Grenoble | Grenoble | |
France | University Hospital Grenoble | Grenoble | |
France | Clinic Beau Soleil | Montpellier | |
France | Medical pratice (angiology) | Tarbes | |
France | Medical practice (angiology) | Valence |
Lead Sponsor | Collaborator |
---|---|
Association Francaise pour la Recherche Thermale | Floralis, University Hospital, Grenoble |
France,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apnea-Hypopnea Index (AHI) | Variation in AHI according to the allocation group | 4.5 months | |
Secondary | Specific Quality of life | Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency) | 4.5 months | |
Secondary | Global Quality of life | Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale) | 4.5 months | |
Secondary | 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 | 4.5 months | |
Secondary | Nocturnal hypoxemia | Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90% | 4.5 months | |
Secondary | 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 | 4.5 months | |
Secondary | Sleep duration | Mean sleep duration is assessed by actigraphy over a period of 7 days. | 4.5 months | |
Secondary | Quality of Sleep | Quality of sleep is assessed by Quebec Quality of life Questionnaire | 4.5 months | |
Secondary | Daytime sleepiness | Sleepiness is assessed by Epworth sleepiness scale | 4.5 months | |
Secondary | Variation of interstitial fluid | bioimpedance is used to measure interstitial fluid | 4.5 months | |
Secondary | Long term efficacy | Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP | 1 year | |
Secondary | Venous insufficiency classification | Variation of venous insufficiency is assessed by CEAP classification | 1 year | |
Secondary | Venous insufficiency variation | Variation of venous insufficiency is assessed by Villalta score | 1 year | |
Secondary | Venous insufficiency examination | Variation of venous insufficiency is assessed by leg circumferences | 1 year | |
Secondary | 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) | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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). | 1 year | |
Secondary | 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. | 4.5 months |
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