DeliriumNCT02691013
The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
A study testing Ramelteon in people with Delirium and Sleep Deprivation, run by University of California, San Diego.
Trial summary
Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Delirium, Sleep Deprivation
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
- Age > 18 years
Who cannot join
- Pregnancy
- Cirrhosis of any etiology
- Current use of any atypical antipsychotic including Fluvoxamine (contra-indicated with Ramelteon)
- Any contraindication to EEG/Sleep recording
- Non-English speaking (who are unable to complete delirium questionnaires)
About this study
Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). In order to improve sleep quality, the investigators will conduct a study of Ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep.
- Conditions
- Delirium, Sleep Deprivation
- Being tested
- Ramelteon, Placebo
- Medical subject headings
- Delirium, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive a Placebo tablet every evening. Receives: Drug: Placebo |
| Ramelteon | Active comparator | Patients will receive Ramelteon 8mg every evening. Receives: Drug: Ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Delirium
Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
Measured: Twice daily for up to 10 days
Total Duration of Sleep
Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time.
Measured: Daily for up to 10 days
Secondary outcomes (6)
Number of Participants With Delirium
Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
Measured: Twice daily for up to 10 days
Average Daily Critical Care Pain Observation Tool (CPOT)
average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation.
Measured: 10 days
Length of Hospital Stay
Measured: Duration of hospital admission
Length of ICU Stay
Measured: Duration of hospital admission
Measures of Light Quality in the Patient's Room
Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.
Measured: 3 days
Measures of the Sound Levels in the Patient's Room
Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion31 Dec 2017
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Robert Owens, Principal investigator, 8686577118
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691013
- Sponsor's protocol ID
- 151294
- Status last verified
- Feb 2022
- First submitted
- 28 Dec 2015
- Last updated
- 8 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15.
PubMed 20845391Bellapart J, Boots R. Potential use of melatonin in sleep and delirium in the critically ill. Br J Anaesth. 2012 Apr;108(4):572-80. doi: 10.1093/bja/aes035.
PubMed 22419624Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320.
PubMed 24554232Jaiswal SJ, Bagsic SRS, Takata E, Kamdar BB, Ancoli-Israel S, Owens RL. Actigraphy-based sleep and activity measurements in intensive care unit patients randomized to ramelteon or placebo for delirium prevention. Sci Rep. 2023 Jan 26;13(1):1450. doi: 10.1038/s41598-023-28095-0.
PubMed 36702822Jaiswal SJ, Vyas AD, Heisel AJ, Ackula H, Aggarwal A, Kim NH, Kerr KM, Madani M, Pretorius V, Auger WR, Fernandes TM, Malhotra A, Owens RL. Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy. Crit Care Med. 2019 Dec;47(12):1751-1758. doi: 10.1097/CCM.0000000000004004.
PubMed 31567351
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
- ClinicalTrials.gov ID
- NCT02691013
- Acronym / sponsor ID
- 151294
- Conditions
- Delirium, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). In order to improve sleep quality, the investigators will conduct a study of Ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a Placebo tablet every evening. |
| Ramelteon | Active comparator | Drug: RamelteonPatients will receive Ramelteon 8mg every evening. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
- Age > 18 years
Key exclusion criteria (5 listed)
- Pregnancy
- Cirrhosis of any etiology
- Current use of any atypical antipsychotic including Fluvoxamine (contra-indicated with Ramelteon)
- Any contraindication to EEG/Sleep recording
- Non-English speaking (who are unable to complete delirium questionnaires)
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 |
|---|---|---|
| Ramelteon | Drug | Ramelteon |
| Placebo | Drug | Placebo |
Primary outcome
Duration of Delirium
Time frame: Twice daily for up to 10 days
Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
Total Duration of Sleep
Time frame: Daily for up to 10 days
Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time.
6 secondary outcomes
Number of Participants With Delirium
Time frame: Twice daily for up to 10 days
Average Daily Critical Care Pain Observation Tool (CPOT)
Time frame: 10 days
Length of Hospital Stay
Time frame: Duration of hospital admission
Length of ICU Stay
Time frame: Duration of hospital admission
Measures of Light Quality in the Patient's Room
Time frame: 3 days
Measures of the Sound Levels in the Patient's Room
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20845391Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15.
- Background: PubMed 22419624Bellapart J, Boots R. Potential use of melatonin in sleep and delirium in the critically ill. Br J Anaesth. 2012 Apr;108(4):572-80. doi: 10.1093/bja/aes035.
- Background: PubMed 24554232Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320.
- Derived from this study: PubMed 36702822Jaiswal SJ, Bagsic SRS, Takata E, Kamdar BB, Ancoli-Israel S, Owens RL. Actigraphy-based sleep and activity measurements in intensive care unit patients randomized to ramelteon or placebo for delirium prevention. Sci Rep. 2023 Jan 26;13(1):1450. doi: 10.1038/s41598-023-28095-0.
- Derived from this study: PubMed 31567351Jaiswal SJ, Vyas AD, Heisel AJ, Ackula H, Aggarwal A, Kim NH, Kerr KM, Madani M, Pretorius V, Auger WR, Fernandes TM, Malhotra A, Owens RL. Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy. Crit Care Med. 2019 Dec;47(12):1751-1758. doi: 10.1097/CCM.0000000000004004.
- Individual participant dataSharing planned: No
Related trials for Delirium
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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.
Robert Owens principal investigator
8686577118
Questions about this trial
What is this clinical trial studying?
A study testing Ramelteon in people with Delirium and Sleep Deprivation, run by University of California, San Diego.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Delirium (time frame: Twice daily for up to 10 days). The study lists 2 primary outcomes in all. 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 NCT02691013, which also lists 5 linked publications.
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 8 Feb 2022.