Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The purpose of this study is to analyze the effect of speech therapy on quality of life, sleep quality, daytime sleepiness level and apnea-hypopnea index in patients with hypertensive patients with mild obstructive apnea syndrome.
详细描述
The database will include demographic characteristics, cardiovascular risk factors and and target-organ damages. Anthropometric measurements (height, weight, and abdominal and neck circumference) will be registered. Daytime sleepiness, quality of sleep and quality of life wiill be evaluated through the respective questionnaires: Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI) and SF-36. In order to evaluate the airway, the Mallampati grade will be used in addition to the adapted assessment protocol from Guimarães (2009). The differences between the final score and the baseline score will be calculated and adjusted by the baseline value found in each of the questionnaires applied. Finally, the analysis excluding the patients with suboptimal adherence to speech therapy treatment (less than 85%) compared to the control group will be redone. If there are benefits of treatment with speech therapy, it will also be offered to the control group after the end of the clinical trial. Statistical analysis will be done in the statistical package SPSS version 19.0 package (SPSS Inc. Chicago, Illinois, USA). Data obtained may be of benefit to future patients and will be used only for statistical purposes. The confidentiality of the information collected will be guaranteed, thus ensuring the privacy and confidentiality of the information. In addition, the data obtained will not be used for other purposes not foreseen in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in follow-up in the Hypertension Program (ProHart) at Hospital Universitário Clementino Fraga Filho - UFRJ at least six months;
- •Patient with Resistant Hypertension and Mild Obstructive Sleep Apnea detected by polysomnography;
- •All participants that give written informed consent.
排除标准
- •Age> 85 years;
- •Cognitive deficit that prevents speech therapy;
- •Severe clinical events in the last 6 months;
- •Refusal of the patient to participate in the study;
- •Pregnancy;
- •Prior and regular use of CPAP;
- •Clinical data suggestive of neurological disease with cognitive and / or motor sequelae, craniofacial malformation, severe upper airway obstruction, Neuromuscular disease, users of hypnotic drugs
研究组 & 干预措施
Speech therapy Group
25 patients will be treated with speech therapy, once a week, during 40 minutes for 12 weeks. Oropharyngeal exercises will be performed under the supervision of a speech therapist. Patients will perform the oropharyngeal exercises at home every day.
干预措施: Speech therapy (Other)
Control Group
25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.
干预措施: Control (Other)
结局指标
主要结局
Changes in Pittsburgh Sleep Quality Index (PSQI)
时间窗: Five months
Changes found in score after 12 weeks in control group and speech therapy group. O questionário de Pittsburgh permite avaliar o sono de forma qualitativa e quantitativa, de forma padronizada, ao determinar os "bons dormidores" e "maus dormidores". O questionário avalia parâmetros quantitativos, tais como a duração do sono, latência do sono e número de despertares; e parâmetros qualitativos, que são puramente subjetivos.
Changes in Epworth sleepiness scale
时间窗: Five months
Changes found in score after 12 weeks in control group and speech therapy group. The ESS measures EDS levels, assigning a score (from 0 to 3) according to the possibility of sleeping in each mentioned situation. A score from 0 to 6 is considered normal; from 7 to 9, limitrophe; 10 to 14, mild sleepiness; 15 to 20, moderate sleepiness; and above, severe sleepiness. Values ≥11 are generally associated with sleep disorders.
Changes in SF-36
时间窗: Five months
Changes found in score after 12 weeks in control group and speech therapy group. The SF-36 consisting of 36 items grouped into eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health. It assesses both negative (illness or disease) and positive aspects (well-being), with a score from 0 to 100, with zero being the worst health condition and 100 being the best, with each dimension being analyzed separately.
次要结局
- Qualitative assessment of Speech Therapy Assessment(Four months)
- Apnea-hypopnea index(Three months after Clinical evaluation initial)
研究者
Alessandra Bastos de Sousa
Master student
Universidade Federal do Rio de Janeiro