A Phase 4 interventional study of Chloral Hydrate in Insomnia, Insomnia Chronic and Chloral Hydrate, sponsored by Pharmanovia. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Pharmanovia · Phase 4, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 100 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →This is the only study on the registry with Pharmanovia as lead sponsor.
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Exclusion Criteria:
Drug: Chloral Hydrate
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.
To assess the effectiveness of Chloral Hydrate in reducing insomnia severity
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index
Time frame: Self-rated insomnia severity, assessed at baseline and 2 weeks
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)
Time frame: 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.
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
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)
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
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.
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
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)
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
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Time frame: 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
Time frame: AEs and SAEs for the 6 week trial duration
To investigate intervention adherence
Daily intervention adherence for the duration of the intervention (2 weeks)
Time frame: 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
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
Change in 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
Change in 1. Concomitant 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
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.
Time frame: CGI-S assessed at baseline, and CGI-I assessed at 2 weeks and 6 weeks
To assess days off work
Change in percentage of 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)
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→