Comparison between interval titration study with conventional overnight titration study in patients with Obstructive Sleep Apnoea: A Prospective, randomized Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. To compare the sleep efficiency among patients with conventional overnight CPAP titration and those with interval CPAP titration using polysomnography.
研究概览
简要总结
A trial of CPAP before the titration study could give the patient time to adjust to the CPAP and could improve the study efficiency. Hence, we propose that a trial of CPAP before the titration could improve sleep efficiency, reduce mean CPAP pressure during the titration study, reduce CPAP-related anxiety, and improve long-term compliance with CPAP.
After obtaining the informed written consent, patients who meet the inclusion criteria are randomized into two groups (Group A & B) using a computer-generated randomization table. The study will begin after approval from the institutional ethics committee and the medical superintendent. Patients belonging to Group A will receive a CPAP titration study the following night (conventional CPAP titration study). Patients belonging to group B will receive auto CPAP for a minimum duration of two weeks, followed by a level 1 overnight CPAP titration study (interval CPAP titration study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients diagnosed to have obstructive sleep apnea (AHI≥15) using a level 5 polysomnography are included in the study.
排除标准
- •Age less than 18 years b.
- •Patients who refuse to give consent c.
- •Patients with known psychiatric disorders d.
- •Patients with hemodynamic instability e.
- •Patients who are not willing to use CPAP.
结局指标
主要结局
1. To compare the sleep efficiency among patients with conventional overnight CPAP titration and those with interval CPAP titration using polysomnography.
时间窗: Interval titration group: | Baseline: sleep efficiency using titration study | Anxiety score using BAI | At 3 Months: Compliance to CPAP using questionnaire | Anxiety score using BAI | Conventional overnight titration group: | Baseline: sleep efficiency using titration study | Anxiety score using BAI | At 3 Months: Compliance to CPAP using questionnaire | Anxiety score using BAI
2. To compare the acceptability of CPAP among patients with conventional overnight CPAP titration and those with interval CPAP titration using a CPAP perception questionnaire.(9)
时间窗: Interval titration group: | Baseline: sleep efficiency using titration study | Anxiety score using BAI | At 3 Months: Compliance to CPAP using questionnaire | Anxiety score using BAI | Conventional overnight titration group: | Baseline: sleep efficiency using titration study | Anxiety score using BAI | At 3 Months: Compliance to CPAP using questionnaire | Anxiety score using BAI
3. To compare the CPAP compliance at three months among those with overnight and interval CPAP titration using a proforma.
时间窗: Interval titration group: | Baseline: sleep efficiency using titration study | Anxiety score using BAI | At 3 Months: Compliance to CPAP using questionnaire | Anxiety score using BAI | Conventional overnight titration group: | Baseline: sleep efficiency using titration study | Anxiety score using BAI | At 3 Months: Compliance to CPAP using questionnaire | Anxiety score using BAI
次要结局
-  To compare the level of anxiety among patients who underwent overnight CPAP titration study and those with interval CPAP titration at baseline and three months using the BAI questionnaire(At baseline, 3 months)
研究者
Thomas Antony
Kasturba Medicall College