Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Syncope, Vasovagal
- Sponsor
- PEAS (Pole d'Exploration des Apnees du Sommeil)
- Enrollment
- 60
- Locations
- 8
- Primary Endpoint
- Change in 6-month syncope rate
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a multi-centre, registry-based study whose primary objective is to evaluate the effect of treatment for sleep apnoea syndrome (SAS) on the number of syncope/malaise episodes in a population suffering from both idiopathic, recurrent vasovagal syncope/malaises and SAS.
Detailed Description
Treatment for sleep apnoea syndrome includes continuous positive airway pressure (CPAP) or a mandibular advancement device (MAD). Additional routine follow-up includes 24 hour holter monitoring on a yearly basis, polysomnography on a yearly basis, multiple sleep latency tests, table tilt tests.
Investigators
Vincent Puel
Study Director
PEAS (Pole d'Exploration des Apnees du Sommeil)
Eligibility Criteria
Inclusion Criteria
- •Obstructive sleep apnoea syndrome (\>15 respiratory micro awakenings per hour of sleep) with an indication for treatment
- •Recurring vasovagal syncope episodes defined as follows: at least three vasovagal syncopes during the last two years - OR- symptoms of orthostatic intolerance occurring in the last 6 months (Symptoms are triggered by orthostatism and can include malaises without loss of consciousness, asthenia, dizziness, visual disturbances, tinnitus, palpitations, headache, limitations of physical activity)
Exclusion Criteria
- •Pathology that may explain syncope symptoms
- •Cardiopathy
- •Known disautonomia
- •Hypotension of known origin
- •Adrenal insufficiency
- •Thyroid disorder
- •History of sudden death in a first degree family member
Outcomes
Primary Outcomes
Change in 6-month syncope rate
Time Frame: Month -6 to Day 0 versus Months +6 to +12
Day 0 refers to the initiation of sleep apnea treatment. The baseline syncope rate refers to syncope events occurring between month -6 and day 0 (S_before). The post-treatment syncope rate refers to syncope events occurring between months +6 and +12(S_after). The change is rates is S_before minus S_after.
Secondary Outcomes
- Patient-reported position of syncopes/malaises(Yearly visit (month 12))
- Patient-reported frequency of signs preceding a loss of consciousness(Yearly visit (month 12))
- VAS for snoring(Yearly visit (month 12))
- VAS for nycturia(Yearly visit (month 12))
- 12-item Impact of Syncope on Quality of Life (ISQL) questionnaire(Yearly visit (month 12))
- VAS for nocturnal agitation(Yearly visit (month 12))
- VAS for nocturnal sweating(Yearly visit (month 12))
- Syncope/malaise dates(Day 0 to Month 12)
- Patient-reported sycope/malaise trigger(Yearly visit (month 12))
- VAS for absence of libido(Yearly visit (month 12))
- Patient-reported syncope/malaise frequency(Yearly visit (month 12))
- Patient-reported sycope/malaise timing(Yearly visit (month 12))
- VAS for restless legs(Yearly visit (month 12))
- VAS for palpitations(Yearly visit (month 12))
- VAS for morning headaches(Yearly visit (month 12))
- VAS for gastro-oesophagien reflux(Yearly visit (month 12))
- the Epworth Sleepiness Scale(Yearly visit (month 12))
- Pichot's fatigue scale(Yearly visit (month 12))
- VAS for lack of concentration while driving(Yearly visit (month 12))
- Pichot's depression inventory(Yearly visit (month 12))
- Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))(Yearly visit (month 12))