PE and OSA- Unveiling the Hidden Connection - A Pilot Study
Research type
Research Study
Full title
Investigating the Connection between Pulmonary Embolism (PE) and Obstructive Sleep Apnoea (OSA)
IRAS ID
344603
Contact name
Swapna Mandal
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
The purpose of this study is to evaluate whether patients diagnosed with a pulmonary embolism (PE) also have evidence of undiagnosed sleep disordered breathing (SDB), and whether there is a change in the degree of severity of SDB at three months’ post index event.
This study will be conducted at a single hospital trust, comprised of two sites. Adults (over the age of 18 years) patients diagnosed with an acute pulmonary embolism (and confirmed by imaging- either pulmonary angiogram or ventilation/perfusion scan) will be approached for involvement in the study; this will therefore include patients who are not admitted to hospital but are diagnosed and followed up on an outpatient basis (for example, via an ambulatory general medical clinic). Exclusion criteria include age < 18, pregnancy, known malignancy, known obstructive sleep apnoea (OSA), previous venous thromboembolism (VTE), unstable psychiatric disease and Rockwood Frailty Score > 6.
In patients who are suitable and consent to enrolment, we propose to perform a sleep study within 72 hours of diagnosis of PE, either as an inpatient or outpatient depending on the patient’s initial management plan. Participants will subsequently undergo a routine review at 12 weeks and will undergo a repeat sleep study. Depending on the results of the second sleep study, patients who meet the criteria for a diagnosis of OSA will be offered CPAP therapy as per local guidelines and practice. We plan to compare the results of the two sleep studies to evaluate the potential change in SDB. At each study review (0, 12 and 24 weeks) we will perform validated symptom-based questionnaires (Epworth score, modified MRC score and modified Borg score) to evaluate the participants’ perceptions of their symptom burden, and establish if there is any change noted over time and particularly following initiation of CPAP.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0194
Date of REC Opinion
19 Nov 2024
REC opinion
Further Information Favourable Opinion