PIMA Study. Improvement of adherence and quality of life of obstructive sleep apnea under CPAP treatment through anintervention based on the stratifcation and personalization of care plans: a randomized controlled trial / Estudio pima. Mejora de la adherencia y de la calidad de vida de la apnea obstructiva del sueño en tratamiento con cpap a través de una intervención basada en la estratificación y personalización de los planes de atención: un ensayo controlado aleatorizado

Introducción. El tratamiento de primera línea para la apnea obstructiva del sueño (AOS) es la terapia de presión positiva continua en las vías respiratorias (CPAP). La falta de adherencia es el principal problema de la CPAP. Se necesita un paciente motivado. El objetivo de este estudio es determinar la adherencia a la CPAP y los resultados relacionados con la salud en pacientes con AOS a través de un programa integral basado en estratificación y planes de atención individualizados, utilizando entrevista motivacional. Métodos. Ensayo controlado aleatorizado multicéntrico realizado en 3 hospitales. El grupo de control siguió el tratamiento habitual. El grupo de intervención (PIMA) siguió el tratamiento con un plan de cuidados adaptado basado en variables sociodemográficas, clínicas y psicológicas, utilizando entrevista motivacional. El resultado principal fue la adherencia (90 y 180 días de tratamiento) y los secundarios fueron la calidad de vida, el estado emocional, las actividades, las relaciones sociales, la competencia percibida y la motivación. Resultados. Se aleatorizaron 213 pacientes (grupo PIMA: 108; grupo de control: 105). Se encontró una diferencia estadísticamente significativa en el grupo PIMA versus el grupo control en la adherencia a los 90 y 180 días: 129.24 (IC95% 77.25-181.22) p < 0.0001 y 288.30 (IC95% 187.146-389.47) p < 0.0001. La adherencia (horas/día) fue mayor en el grupo PIMA comparado con el grupo control (90 días) con una diferencia de 1.74 horas/día (IC95% 1.18-2.30) p < 0.0001 y a los 180 días con una diferencia de 2.31 (IC95% 1.72-2.91) p < 0.001. Los resultados secundarios mostraron diferencias significativas a favor del grupo PIMA. Conclusiones. Se encontró evidencia de que un programa basado en estratificación y planes de atención personalizados, utilizando entrevistas motivacionales, mejora la adherencia a la CPAP y la calidad de vida (AU)

Introduction. The first-line treatment for obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP) therapy. Lack of adherence is the main problem with CPAP. A motivated patient is needed. The objective of this study is to determine adherence to CPAP and health-related outcomes in patients with OSA through a comprehensive program based on stratification and individualized care plans, using motivational interviewing. Methods. Multicenter randomized controlled trial (RCT) conducted in 3 hospitals. Control group followed the usual treatment. Intervention group (PIMA) followed the treatment with an adapted care based on sociodemographic, clinical and psychological variables, using motivational interview. The main outcome was adherence (90 and 180 days of treatment), and the secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence, and motivation. Results. 213 patients were randomized (intervention group: 108; control group: 105). A statistically significant difference was found in the intervention group versus the control group in adherence at 90 and 180 days: 129.24 (IC95% 77.25-181.22) p< 0.0001 and 288.30 (IC95% 187.146-389.47) p< 0.0001. Adherence (hours/day) was higher in the PIMA group compared to the control group at 90 days with a difference of 1.74 hours/day (IC95% 1.18-2.30) p< 0.0001 and at 180 days with a difference of 2.31 (IC95% 1.72-2.91) p< 0.001. The secondary results showed significant differences in favour of the PIMA group. Conclusions. Evidence was found that a program based on stratification and personalized care plans, using motivational interviewing, improves adherence to CPAP and quality of life (AU)

A one-arm surgical trial of obstructive sleep apnea (OSA) patients before and 12 months after Bilateral Internal Ramus Distraction of the mandible (BIRD).

BACKGROUND: An innovative approach for the primary and definitive treatment of obstructive sleep apnea (OSA) in adult patients is presented: Bilateral Internal Ramus Distraction of the mandible (BIRD), which is a slow, progressive and more stable procedure to advance the mandibular bone. This study investigated whether this surgical approach is useful to cure OSA. METHODS: Study design was of an interventional (surgical) one-arm trial of OSA patients assessed before and 12 months after BIRD. All patients were evaluated by pre- and post-operative polysomnography and three-dimensional scans. The amount of skeletal advancement, percentage of upper airway volume increase and postoperative value of mandibular occlusal plane were the predictor variables. Changes in the apnoea-hypopnoea index (AHI), oxygen desaturation index (ODI), and percentage of time with saturation under 90% (TC90) were the main outcome variables. FINDINGS: Thirty-two subjects with a mean ± SD age of 41.9 ± 13.3 years and 87.5% male were included, and they were followed-up 32 ± 14.2 months. AHI was 47.9 ± 23.1 per hour before surgery and the Epworth Sleepiness Scale (ESS) was 13.4 ± 4.4. Postoperative AHI was 4.8 ± 5.6 per hour 12 months after surgery (P < 0.001), with 81.2% of the patients considered cured (AHI<5) and 18.8% suffering from a mild-to-moderate residual OSA. ESS decreased to 1.9 ± 1.8 at the end of the surgical treatment (P < 0.001). 3D changes revealed an upper airway volume increase of 188.4% ± 73.5% (P < 0.001). INTERPRETATION: Lengthening the mandibular ramus by distraction osteogenesis to cure OSA appears to be more effective and safer when compared to other surgical protocols, especially in very severe cases with initial AHI>50/h. Titration of the mandibular advancement weekly using respiratory polygraphy allows better healing control and customization of the skeletal advancement, enhancing the aesthetic result.

Maxillomandibular advancement as the initial treatment of obstructive sleep apnoea: Is the mandibular occlusal plane the key?

Maxillomandibular advancement (MMA) can be effective for managing obstructive sleep apnoea (OSA); however, limited information is available on the predictor surgical variables. This study investigated whether normalization of the mandibular occlusal plane (MOP) was a determinant factor in curing OSA. Patients with moderate or severe OSA who underwent MMA were evaluated by preoperative and postoperative three-dimensional (3D) scans and polysomnograms. The postoperative value of MOP and the magnitude of skeletal advancement were the predictor variables; change in the apnoea-hypopnoea index (AHI) was the main outcome variable. Thirty-four subjects with a mean age of 41±14years and 58,8% female were analysed. The Epworth Sleepiness Scale (ESS) was 17.4±5.4 and AHI was 38.3±10.7 per hour before surgery. Postoperative AHI was 6.5±4.3 per hour (P<0.001) with 52.94% of the patients considered as cured, and 47.06% suffering from a mild residual OSA with ESS 0.8±1.4 (P<0.001). 3D changes revealed a volume increase of 106.3±38.8%. The mandible was advanced 10.4±3.9mm and maxilla 4.9±3.2mm. MOP postoperative value was concluded to be the best predictor variable. Treatment planning should include MOP normalization and a mandibular advancement between 6 and 10mm. The maxillary advancement would depend on the desired aesthetic changes and final occlusion.