RESTORE
Research type
Research Study
Full title
An open-label tRial to Evaluate the SafeTy and efficacy Of chloral hydrate in patients with seveRE insomnia (RESTORE)
IRAS ID
1007757
Contact name
Stephen Deacon
Contact email
Sponsor organisation
Pharmanovia (Atnahs Pharma UK Ltd)
Research summary
Persistent insomnia affects approximately 10% of the adult population and is a risk factor for several mental and physical health problems. Severe insomnia can impair quality of life and performance of daily tasks, as well as increasing the risk of disorders such as depression, heart attack, stroke and diabetes.
Current sleep therapies include cognitive behavioural therapy (CBT), where access remains limited, and the use of hypnotics and (off-label) sedative antidepressants, which are associated with side-effects, tolerance and dependence. There is therefore a need to identify additional treatments especially where these treatments fail in cases where insomnia is severe.
Chloral Hydrate is a licensed treatment in the UK for the short-term treatment (2 weeks) in patients with severe insomnia which is interfering with normal daily life, and where other sleep therapies (behavioural and pharmacologic) have failed. However, despite having a long clinical experience, there is a lack of clinical evidence with Chloral Hydrate.
The main aim of this trial is to establish whether short-term Chloral Hydrate treatment (2 weeks) is effective in patients with severe insomnia, assessed by the Insomnia Severity Index (ISI). Patients with severe insomnia which is interfering with normal daily life, and where other behavioural and drug sleep therapies have not been successful, will be recruited to the trial. All enrolment (pre-screening, informed consent, assessment by a sleep specialist, eligibility review by a medical doctor, and collection of baseline data) and follow-up procedures (validated questionnaires, daily/weekly surveys, and safety assessments), during and after Chloral Hydrate treatment will be conducted remotely via telephone/video calls and online questionnaires. An independent and medically qualified safety committee will oversee and monitor safety throughout the trial.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0054
Date of REC Opinion
21 Aug 2023
REC opinion
Further Information Favourable Opinion