InsomniaPhase 4RESTORENCT06053840
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia
A Phase 4 study testing Chloral Hydrate in people with Insomnia and Insomnia Chronic, run by Pharmanovia at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia, Insomnia Chronic, Chloral Hydrate
- What is being tested?
- Chloral Hydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 7 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lindus Health, The Leather Market Weston Street, Bermondsey,
London, SE1 3ER
About this study
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.
- Conditions
- Insomnia, Insomnia Chronic, Chloral Hydrate
- Being tested
- Chloral Hydrate
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloral HydrateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Chloral Hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of Chloral Hydrate in reducing insomnia severity
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index
Measured: Self-rated insomnia severity, assessed at baseline and 2 weeks
Secondary outcomes (12)
To explore whether Chloral Hydrate will affect Self-rated insomnia severity, assessed at baseline and 2 weeks
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)
Measured: Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks
To explore whether Chloral Hydrate will affect Daytime sleepiness
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.
Measured: Epworth Sleepiness Scale scores, assessed at baseline, 1 week, 2 weeks and 6 weeks
To explore whether Chloral Hydrate will affect Insomnia severity
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)
Measured: Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks
To explore whether Chloral Hydrate will affect Health-related quality of life
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.
Measured: SF-36 and EQ-5D-5L responses, assessed at baseline, 1 week, 2 weeks and 6 weeks
To explore whether Chloral Hydrate will affect anxiety and Depression
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)
Measured: HADS scores, assessed at baseline, 1 week, 2 weeks and 6 weeks
To explore whether Chloral Hydrate will affect Quality of sleep and sleep disturbances
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Measured: PSQI responses assessed at baseline, 2 weeks and 6 weeks
To investigate the safety of Chloral Hydrate
Evaluation of overall safety of Chloral Hydrate by the monitoring of AEs and SAEs
Measured: AEs and SAEs for the 6 week trial duration
To investigate intervention adherence
Daily intervention adherence for the duration of the intervention (2 weeks)
Measured: Daily intervention adherence survey questions on days 1-14
To assess tolerance of Chloral Hydrate
Number of participants withdrawn from the IMP due to an AR, during the 2 week treatment period
Measured: Total number of participants withdrawn from the IMP due to an AR
To determine any reductions in the use of non-pharmacological sleep therapies
Change in use of non-pharmacological sleep therapies
Measured: Non-pharmacological sleep therapies assessed at baseline, 1 week, 2 weeks and 6 weeks
To determine any reductions in 1. Concomitant prescribed medication 2. Over the counter medication used to facilitate sleep
Change in
- Concomitant medication
- Over the counter medication used to facilitate sleep
Measured: 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
Medical doctor assessment of effectiveness of Chloral Hydrate
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.
Measured: CGI-S assessed at baseline, and CGI-I assessed at 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Sep 2023
- Primary completion24 Apr 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanovia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053840
- Sponsor's protocol ID
- 1007757
- Acronym
- RESTORE
- Status last verified
- Nov 2024
- First submitted
- 21 Jun 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groeger JA, Twelves JL, Multmeier J, Swayze H, Mastim Snr M, Williams A, Deacon S. Chloral Hydrate in the Treatment of Severe Insomnia When Other Treatments Have Failed: Results From a Real-World Evidence Study (RESTORE). Nat Sci Sleep. 2026 May 19;18:587588. doi: 10.2147/NSS.S587588. eCollection 2026.
PubMed 42199304
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia
- ClinicalTrials.gov ID
- NCT06053840
- Acronym / sponsor ID
- RESTORE / 1007757
- Conditions
- Insomnia, Insomnia Chronic, Chloral Hydrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PharmanoviaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Chloral Hydrate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloral HydrateParticipants 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. | Drug | Treatment |
Primary outcome
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
12 secondary outcomes
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
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
To explore whether Chloral Hydrate will affect Insomnia severity
Time frame: Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks
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
To explore whether Chloral Hydrate will affect anxiety and Depression
Time frame: HADS scores, assessed at baseline, 1 week, 2 weeks and 6 weeks
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
To investigate the safety of Chloral Hydrate
Time frame: AEs and SAEs for the 6 week trial duration
To investigate intervention adherence
Time frame: Daily intervention adherence survey questions on days 1-14
To assess tolerance of Chloral Hydrate
Time frame: Total number of participants withdrawn from the IMP due to an AR
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Derived from this study: PubMed 42199304Groeger JA, Twelves JL, Multmeier J, Swayze H, Mastim Snr M, Williams A, Deacon S. Chloral Hydrate in the Treatment of Severe Insomnia When Other Treatments Have Failed: Results From a Real-World Evidence Study (RESTORE). Nat Sci Sleep. 2026 May 19;18:587588. doi: 10.2147/NSS.S587588. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloral Hydrate in people with Insomnia and Insomnia Chronic, run by Pharmanovia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of Chloral Hydrate in reducing insomnia severity (time frame: Self-rated insomnia severity, assessed at baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.