Skip to main content
OpenTrials
Completed

NCT Number: NCT06053840

An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia

The primary aim of this Real-World Evidence trial is to establish whether short-term (2 weeks) treatment of Chloral Hydrate is effective in patients with severe insomnia which is interfering with normal daily life, and where other behavioural and pharmacologic therapies have failed in a real world setting.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Chloral Hydrate Dyssomnias Insomnia Chronic Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lindus Health, The Leather Market Weston Street, Bermondsey,

London, SE1 3ER, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years and ≤75 years
  • Participant is willing and able to give informed consent
  • Clinically significant impairment from severe insomnia (eg. ISI score 22-28)
  • Previous treatment with sleep therapies (behavioural and pharmacologic), which have failed. Defined as the presence of ongoing severe insomnia (ISI score 22-28), despite previous use of other sleep therapies.
  • Able to adhere to trial procedures
  • Willingness to take a pregnancy test prior to starting IMP treatment (participants of childbearing potential)

Exclusion criteria

  • Pregnant or breastfeeding
  • Taking any substances that significantly affect sleep during the 2 week IMP treatment period
  • Starting any new behavioural sleep therapies* during the 2 week IMP treatment period
  • At point of enrolment taking substances that affects sleep at greater than maximum licensed doses
  • Other sleep diagnosed/suspected sleep disorders (restless legs, periodic limb movements, unusual sleep timings (indicative of advanced/delayed sleep, etc), parasomnias
  • Known severe hepatic impairment
  • Known moderate / severe renal impairment / eGFR <60
  • Known severe sleep apnea
  • Known severe cardiac disease
  • Known cardiac disease with QT prolongation
  • History of myocardial infarction in the last 12 months
  • History of stroke or TIA
  • Taking medication that may cause QT prolongation
  • Active gastritis, oesophagitis, gastric or duodenal ulcers or perforation
  • Susceptible to acute attacks of porphyria
  • Hypersensitivity to Chloral Hydrate or to any of the excipients (glycerol, liquid glucose, citric acid, sodium citrate, sodium benzoate, saccharin sodium, essence of passion fruit [containing natural flavouring, artificial flavouring, propylene glycol], and purified water)
  • Individuals with a history of alcohol or drug abuse or dependence
  • Patients taking antipsychotic medication in last 12 months
  • History of overdose or attempted overdose
  • History of significant psychiatric disease
  • Patients are taking one of the drugs listed as interacting with Chloral Hydrate and would need to continue taking these during the trial: alcohol, CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, antidepressant agents, centrally acting muscle relaxants, narcotic, analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines, intravenous furosemide, anticoagulants.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
  • Participants who have participated in another research trial involving an investigational product in the past 4 months
  • Participants of childbearing potential (participants who are anatomically and physiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptives** for the duration of the trial, and who do not confirm a negative pregnancy test prior to starting the IMP.

Treatment and study plan

Chloral Hydrate

Drug

Participants will be involved in the trial for approximately 7-8 weeks, the first week to collect baseline data and complete screening and eligibility confirmation, the following two weeks they will administer IMP, and there will be a further 4 week observation period. All trial recruitment and follow-up procedures will be conducted remotely via telephone/video calls.

Primary outcomes

  1. To assess the effectiveness of Chloral Hydrate in reducing insomnia severity

    Time frame: Self-rated insomnia severity, assessed at baseline and 2 weeks

    Change in self-rated insomnia severity, assessed using the Insomnia Severity Index

Secondary outcomes

  1. To explore whether Chloral Hydrate will affect Self-rated insomnia severity, assessed at baseline and 2 weeks

    Time frame: Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks

    Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)

  2. To explore whether Chloral Hydrate will affect Daytime sleepiness

    Time frame: Epworth Sleepiness Scale scores, assessed at baseline, 1 week, 2 weeks and 6 weeks

    Change in Epworth Sleepiness Scale scores which is based on a 0-3 scale with 0 being No chance of dozing, and 3 High chance of dozing.

  3. To explore whether Chloral Hydrate will affect Insomnia severity

    Time frame: Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks

    Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)

  4. To explore whether Chloral Hydrate will affect Health-related quality of life

    Time frame: SF-36 and EQ-5D-5L responses, assessed at baseline, 1 week, 2 weeks and 6 weeks

    Change in health-related quality of life, measured using the ShortForm 36 (SF-36) and EQ-5D-5L questionnaires. The SF-36 is based on a 1-5 with 1 being excellent and 5 poor. EQ-5D-5L is scored on a 0-100 scale with 0being the worst health possible, and 100 the best health you can imagine.

  5. To explore whether Chloral Hydrate will affect anxiety and Depression

    Time frame: HADS scores, assessed at baseline, 1 week, 2 weeks and 6 weeks

    Change in Hospital Anxiety and Depression Scale (HADS) scores. The scale is based on a 0-21 scale with 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)

  6. To explore whether Chloral Hydrate will affect Quality of sleep and sleep disturbances

    Time frame: PSQI responses assessed at baseline, 2 weeks and 6 weeks

    Change in Pittsburgh Sleep Quality Index (PSQI) scores

  7. To investigate the safety of Chloral Hydrate

    Time frame: AEs and SAEs for the 6 week trial duration

    Evaluation of overall safety of Chloral Hydrate by the monitoring of AEs and SAEs

  8. To investigate intervention adherence

    Time frame: Daily intervention adherence survey questions on days 1-14

    Daily intervention adherence for the duration of the intervention (2 weeks)

  9. To assess tolerance of Chloral Hydrate

    Time frame: Total number of participants withdrawn from the IMP due to an AR

    Number of participants withdrawn from the IMP due to an AR, during the 2 week treatment period

  10. To determine any reductions in the use of non-pharmacological sleep therapies

    Time frame: Non-pharmacological sleep therapies assessed at baseline, 1 week, 2 weeks and 6 weeks

    Change in use of non-pharmacological sleep therapies

  11. To determine any reductions in 1. Concomitant prescribed medication 2. Over the counter medication used to facilitate sleep

    Time frame: 1. Concomitant medication assessed at baseline, 1 week, 2 weeks and 6 weeks 2. Over the counter medication used to facilitate sleep assessed at baseline, 1 week, 2 weeks and 6 week

    Change in

    • Concomitant medication
    • Over the counter medication used to facilitate sleep

  12. Medical doctor assessment of effectiveness of Chloral Hydrate

    Time frame: CGI-S assessed at baseline, and CGI-I assessed at 2 weeks and 6 weeks

    Clinical Global Impressions - Severity Scale (CGI-S) assessed at baseline, and Clinical Global Impressions - Improvement scale (CGI-I) assessed after IMP treatment by the medically qualified doctor. Rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

Other outcomes

  1. To assess days off work

    Time frame: Percentage of days off work one month and 12 months prior to baseline, and assessed at 2 weeks (for the 2 week treatment period) and 6 weeks (for the 4 week observation period)

    Change in percentage of days off work

Sponsors and collaborators

Lead sponsor

Pharmanovia

Industry

Registry information

Acronym: RESTORE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2023
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.