Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation. The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.
Obstructive sleep apnea (OSA) syndrome had become over the last decade a serious health concern due to its high prevalence which raise 10% of the general population. It is characterized by recurrent episodes of airflow obstruction in the upper airway (UA) consequence of passive collapse of the UA, particularly at the tongue level. These collapses induce recurrent asphyxia that results in oxygen desaturations with persistant and crescendo respiratory efforts inducing arousals from sleep. Indeed, despite its large efficacy some of the patients will never accept continuous positive airway pressure treatment or will not tolerate. To this extent, alternative treatement has been developed: implanted hypoglossal stimulation. This treatment has been developed by Inspire Medical Device. The Inspire® system is intended to prevent base-of-tongue obstruction as well as specific soft palate obstructions by stimulating the hypoglossal nerve synchronous with respiration. A selection processus will be applied in order to identify the patients that will be good responders to the hypoglossal stimulation. The main criterion of selection is based on Drug Induced Sleep Endoscopy(DISE) that will be performed by a trained endoscopist dedicated to this study. This sleep endoscopy allows to visualize during induced sleep the shape of the UA and the type of collapsus. Indeed an antero-posterior collapsus is related to a good response to hypoglossal nerve stimulation while complete concentric obstruction at velopharyngeal is a predictor of poor response. In this pilot study, the investigators evaluate as a primary outcome the delta range of blood pressure during sleep but also other cardiovascular indexes targeting blood pressure and heart rate variability as secondary outcomes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
7
At first, INSPIRE® device will be active a month
After 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.
UniversityHospitalGrenoble
Grenoble, France
Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).
Time frame: one month treatment active versus non active treatment
Short-term efficacy of a new treatment for OSA on mean-24h, daytime and nighttime blood pressure
Ambulatory 24h arterial blood pressure
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on OSA by Epworth sleepiness scale score
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person has daytime sleepiness.
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on Apnea-Hypopnea Index measured by polysomnography
Apnea-Hypopnea Index expressed in number per hour
Time frame: one month treatment active versus non active treatment
Change in sympatho-vagal balance based on heart rate variability analysis
ECG polysomnography
Time frame: one month treatment active versus non active treatment
Self-reported changes in sleep and quality of life by SF-36 score
The SF-36 is a 36-item scale constructed to survey health status and quality of life (Ware \& Sherbourne, 1992), assessing eight health concepts: limitations in Quality of life physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points. The SF-36 has been widely used and has excellent psychometrics.
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Time frame: one month treatment active versus non active treatment
Sleep latency assessed during a Maintenance of Wakefulness Test
Mean sleep latency from the 4 sessions of the Maintenance of Wakefulness Test
Time frame: one month treatment active versus non active treatment
Nocturnal pulse pressure assessed by Continuous Non-invasive Arterial Pressure monitoring
Pulse pressure variability indexe DeltaBP in mmHg.
Time frame: one month treatment active versus non active treatment
Short-term efficacy of a new treatment for OSA on diastolic blood pressure variability during sleep
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on OSA by Pichot weakness scale score
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 5-point scale (0-4), their usual feeling of tiredness or weakness while engaged in eight different activities. The PWS score (the sum of 8 item scores, 0-4) can range from 0 to 32. The higher the PWS score, the higher that person has weakness.
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on nocturia
Assessment of nocturia number by nigt
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on morning asthenia
Patients are asked to assess, on a visual analogic scale morning asthenia. The items use a visual analogic scales from 0 to 10 points.
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on morning headache
Patients are asked to assess, on a visual analogic scale morning headache. The items use a visual analogic scales from 0 to 10 points.
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on snoring
Patients are asked to assess, on a visual analogic scale snoring. The items use a visual analogic scales from 0 to 10 points.
Time frame: one month treatment active versus non active treatment
Self-reported changes in sleep and quality of life by FOSQ score
This is a disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The 5 domains that the FOSQ measures are as follows: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty).
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on oxygen desaturation index measured by polysomnography
Oxygen desaturation index expressed in number
Time frame: one month treatment active versus non active treatment
Clinical efficacy of this new treatment on sleep efficacy measured by polysomnography
Sleep efficacy expressed by ratio of total sleep time on total sleep period
Time frame: one month treatment active versus non active treatment