In growing subjects, obstruction of the upper airway may lead to excessive vertical facial development. According to the soft-tissue stretching hypothesis (Solow and Kreiborg, 1977) this could be due to an increased cranio-cervical angulation triggered by the airway obstruction. The present study aimed to examine the effect of airway obstruction on cranio-cervical posture in a sample of adult patients with severe obstructive sleep apnoea (OSA). Lateral cephalometric radiographs taken in the natural head position (mirror position) were obtained from 50 male patients aged 28-70 with polysomnographic diagnosis of obstructive sleep apnoea. The Apnoea Index ranged from 21 to 98 episodes per hour with a mean of 54.6. Control samples were available from previous cephalometric studies of head posture in five samples of healthy subjects and one sample of congenitally blind subjects. The average cranio-cervical angle, NSL/OPT, was found to be extremely large (mean 104.1, SD 9.1) exceeding the average values in the control samples by 1-2 standard deviations (P < 0.001). It is suggested that the large cranio-cervical angle in OSA patients is a physiological adaptation aiming to maintain airway adequacy while the head, and thus the visual axis, is kept in its natural relationship to the true vertical. The findings thus provide evidence for the hypothesis that upper airway obstruction may trigger an increase in the cranio-cervical angulation.
on behalf of the HAROSA I Study Group * BACKGROUND: Excessive daytime sleepiness (EDS) in individuals with OSA syndrome persisting despite good adherence to CPAP is a disabling condition. Pitolisant is a selective histamine H3-receptor antagonist with wake-promoting effects.RESEARCH QUESTION: Is pitolisant effective and safe for reducing daytime sleepiness in individuals with moderate to severe OSA adhering to CPAP treatment but experiencing residual EDS? STUDY DESIGN AND METHODS: In a multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was titrated individually at up to 20 mg/day and taken over 12 weeks. The primary end point was change in the Epworth Sleepiness Scale (ESS) score in the intention-totreat population. Key secondary end points were maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, Clinical Global Impressions scale of severity, the patient's global opinion, EuroQoL quality-of-life questionnaire score, Pichot fatigue questionnaire score, and safety.RESULTS: Two hundred forty-four OSA participants (82.8% men; mean age, 53.1 years; mean Apnea Hypopnea Index with CPAP, 4.2/h; baseline ESS score, 14.7) were randomized to pitolisant (n ¼ 183) or placebo (n ¼ 61). ESS significantly decreased with pitolisant compared with placebo (À2.6; 95% CI, -3.9 to À1.4; P < .001), and the rate of responders to therapy (ESS # 10 or change in ESS $ 3) was significantly higher with pitolisant (71.0% vs 54.1%; P ¼ .013). Adverse event occurrence (mainly headache and insomnia) was higher in the pitolisant group compared with the placebo group (47.0% and 32.8%, respectively; P ¼ .03). No cardiovascular or other significant safety concerns were reported.INTERPRETATION: Pitolisant used as adjunct to CPAP therapy for OSA with residual sleepiness despite good CPAP adherence significantly reduced subjective and objective sleepiness and improved participant-reported outcomes and physician-reported disease severity.
The present cephalometric study aimed to describe the antero-posterior diameters of the pharyngeal airway in a sample of 50 male obstructive sleep apnoea (OSA) patients and a reference sample of 103 male students, and to examine the relationship between these diameters and the posture of the head and the cervical column. Subjects were recorded in the cephalometer standing with the head in its natural position (mirror position). Pharyngeal airway diameters were measured at seven levels ranging from the maxillary tuberosity to the vallecula of the epiglottis. The largest difference was observed at the level behind the soft palate where the diameter was 50 per cent narrower in the OSA sample than in the reference sample. Extension of the cranio-cervical angle and forward inclination of the cervical column were correlated with an increase in the three most caudal airway diameters in the OSA sample: at the uvula, the root of the tongue, and the epiglottis, but only to increase in the lowest diameter in the reference sample. The findings were considered to reflect a compensatory physiological postural mechanism that serves to maintain airway adequacy in OSA patients in the awake erect posture, most efficiently so at the lowest levels of the oropharyngeal airway.
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