Aims

To conduct a social scientific study of stakeholder views on the medical, social and ethical aspects of sleep and wakefulness drugs and their role in the management of sleep (‘problems’).

Objectives

The study will provide primarily qualitative data on:

To contribute, on the basis of these data, to:

• Future policy and practice regarding sleep and wakefulness promoting drugs, and to broader debates on the public health and safety aspects of sleep for society.

The study will therefore address both development and regulation issues regarding sleep and wakefulness medications and issues concerning their meaning and use in clinical practice and everyday life.

Ethics and Governance

Full NHS ethical approval for the study was granted in May 2011. As of the end of August 2011, the project team had received the necessary R&D approvals, agreement letters and letters of access to conduct the research in six NHS Trusts across the UK. Five NHS Trusts (Coventry PCT, Warwickshire PCT, Oxford Radcliffe Hospitals NHS Trust, Guy’s and St. Thomas NHS Trust, South Tees NHS Trust) have agreed to be research sites and one Trust (West Midlands Ambulance Service NHS Trust) will be acting as a Participant Identification centre. The research will also take place at several non-NHS sites including the University of Warwick.

Methods

A multi-method study, including documentary research, interviews, and focus groups with key stakeholders in the field.

User Groups and Dissemination Strategy

The project is relevant to a wide range of user groups including: The British Sleep Society; The Royal Society of Medicine (Sleep Medicine section); the British Medical Association; the Association of the British Pharmaceutical Industry; the UK Narcolepsy Association; the Patients' Association and other patient support groups in the sleep field; the Mental Health Foundation; Age UK; The National Union of Students; the Trades Union Congress and its affiliates. Findings from study will be disseminated to all relevant user groups via an executive summary. A one day dissemination event will also be held involving representatives from key users groups regarding the implications of the study for future policy and practice in this area.