A Pilot Cross-sectional Study of the Prevalence of Sleep Disordered Breadthing and Sleep Apnnea in Treated Locoregionally Controlled Head and Neck Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To detect incidence of SBD(sleep disordered breathing)and OSAHS(obstructive sleep apnea hypopnea syndrome)in treated locoregionally controlled Head and Neck cancer patients.
研究概览
简要总结
This observational cross-sectional study explores the hypothesis that the upper airway in patients who have undergone therapy for head and neck cancer either in the form of major reconstructive surgery with/without radiotherapy alone or chemoradiation ,would have long tem upper airway distortion ,inflammation ,fibrosis and loss of tone and calibre.This could cause significant upper airway collapse during sleep causing Sleep disordered Breadthing (SDB) and Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).SDB is widely prevalent and underdiagnosed and causes compromised quality of life with remarkable improvement with treatment.This problem has never been studied in the subset of Head and neck cancer patients in India .A significant association between the two could ,by early detection and treatment,significantly improve the Quality of Life and could provide a rationale for introduction of routine Polysomnography in follow up of all treated Head and Neck Cancer patients, considering that Oral Cancers constitute a large proportion of cancers treated at our institution.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Locoregionally controlled oral and oropharyngeal tumours who have completed treatment atleast 6 months prior to study in the form of either surgery or radiotherapy or surgery and radiotherapyor chemoradiation with the following surgical types: 1.mandibular resection either middle third ,hemi or extended hemimandibulectomy 2.more than hemiglossectomy 3.total glossectomy 4.oropharyngeal resection not involving larynx 5.major resection causing significant alteration of upper airway anatomy with major reconstruction.
排除标准
- •1.Laryngeal tumours or resections or patients who have a tracheostomy2.Haemodynamically unstable patients3.Patients already diagnosed pre-treatment as SDB/OSAHS.
结局指标
主要结局
To detect incidence of SBD(sleep disordered breathing)and OSAHS(obstructive sleep apnea hypopnea syndrome)in treated locoregionally controlled Head and Neck cancer patients.
时间窗: NA
次要结局
- To study quality of life and mental health of these patients and ascertain any association with SDB and OSAHS.(NA)