Impact of obstructive sleep apnea diagnosis on healthcare resource utilization in patients with obstructive lung disease

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31027
• EU PAS number:
  EUPAS19984
• Study ID:
  31027
• Official title and acronym:
  Impact of obstructive sleep apnea diagnosis on healthcare resource utilization in patients with obstructive lung disease
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A historical observational database study UK using primary care data to evaluate the frequency of continuous positive airway pressure (CPAP) therapy prescribing in patients with sleep-related breathing disorder (SBD, including obstructive sleep apnoea). The study will assess SBD patient characteristics (clinical and demographic) in those in whom CPAP treatment is recorded/coded (vs not recorded). Finally the study will evaluate the impact of (i) CPAP and (ii) a SBD diagnosis (as a proxy for CPAP treatment) and (iii) an OSA diagnosis on clinical outcomes and healthcare resource utilization in a representative SBD population of patients in the United Kingdom with comorbid obstructive lung disease.
• Study status:
  Finalised

Research institution and networks

Institutions

Respiratory Effectiveness Group

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 16/12/2016

Actual: 16/12/2016

Study start date

Planned: 01/12/2017

Actual: 01/06/2018

Data analysis start date

Planned: 01/02/2018

Date of final study report

Planned: 30/09/2018

Actual: 30/09/2018

Sources of funding

Other

More details on funding

Respiratory Effectiveness Group

Study protocol

Initial protocol

OSA and Comorbid OLD_Pilot Study Protocol_REG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable