Positive airway pressure in older people: a randomised controlled trial

Not Applicable

Completed

• Conditions: Sleep apnoea; Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN90464927
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

Current inclusion criteria as of 07/04/2010:
1. Aged greater than 65 years, either sex
2. A clinical diagnosis of OSAHS: more than/equal to 4% oxygen desaturation index greater than 7.5 events/hour and an Epworth sleepiness scale more than/equal to 9
3. Ability to give written informed consent

Previous inclusion criteria at time of registration:
1. Both males and females, aged greater than 65 years
2. Apnoea hypopnoea index greater than or equal to 15 events/hour of sleep on multi-channel sleep study, and at least two symptoms of excessive daytime sleepiness or Epworth sleepiness scale greater than or equal to 11
3. Written informed consent

Exclusion Criteria

1. Previous exposure to nasal CPAP therapy
2. Arterial oxygen saturation less than 93%
3. Forced expiratory volume in one second (FEV1) less than 65% predicted
4. Substantial problems with sleepiness driving (in those who are still driving); currently using Heavy Goods Vehicle (HGV) or Public Service Vehicle (PSV) driving licence (where applicable)
5. Shift work
6. Inability to give informed consent or comply with the protocol
7. Irreversible visual impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified