InsomniaPhase 4NCT01207050
Effect of Rozerem on Sleep Among People With Traumatic Brain Injury
A Phase 4 study testing Ramelteon in people with Insomnia and Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Brain Injury
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of traumatic brain injury (TBI) as determined by any of the following at least 1 month prior to study entry:
- Glasgow Coma Scale Score < 15
- Loss of consciousness greater than 5 minutes
- Post traumatic amnesia greater than 30 minutes
- Abnormal neuro-imaging findings after TBI
- Evidence of neurologic deficit as a result of TBI
Show all 14Show fewer
- Endorsement of any of the following by self-report or proxy-report:
- Problems falling or staying asleep
- Daytime sleepiness or fatigue (either cognitive or physical)
- These symptoms must be identified as having an onset after TBI
- Score of > 5 on the Pittsburgh Sleep Quality Index (PSQI)
- Typical bedtime between 8pm and midnight with wake-up time between 6am and 10am on weekdays.
- Must be living in the community
- In the opinion of the Study Team, the participant must be deemed reliable and likely to make all study visits
Who cannot join
- Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the actigraph
- Individuals using other known hypnotic agents (i.e., benzodiazepines, diphenhydramine, zolpidem) will be considered for participation but must have refrained from using sleep medication for two weeks prior to the study and throughout the course of the study
- Movement disorder or spasticity affecting both upper extremities
- Severe pain or history of chronic pain
- Individuals with multiple musculoskeletal injuries
- Taking luvox or fluvoxamine (medication that potentially interact with ramelteon
Show all 9Show fewer
- Liver disease
- Patients who are ventilator-dependent
- Penetrating head TBI
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Foundation Research Center
West Orange, New Jersey, 07052
About this study
Official title: Pilot Study: The Effect of Rozerem on Sleep Disturbance After Traumatic Brain Injury
This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.
Read the detailed description
Although research has begun to examine sleep quality within the traumatic brain injury (TBI) population, most of the studies found in the research literature utilize subjective, self-report measures that can be problematic in terms of response accuracy when used with populations that have known cognitive deficits (Baños, LaGory, Sawrie, Faught, Knowlton, Prasad, Kuzniecky and Martin, 2004). Because TBI often results in a diminished capacity for self-reflective awareness, obtaining reliable sleep-related information is difficult to do through surveys alone (Fleming, Strong, Ashton, 1996; Vanderploeg, Belanger, Duchnick, and Curtiss, 2007).
A number of studies have attempted to objectify the measurement of sleep quality in TBI rehabilitation by having nursing staff keep an overnight log to document whether the patient was asleep or awake at hourly intervals (Burke, Shah, Schneider, Ahangar, \& Al Aladai, 2004; Worthington \& Melia, 2006). Because this results in only one single observation point per hour, it misses the nuances of the sleep/wake cycle obtained through more continuous measurement throughout the night and is still somewhat subjective and dependent on the observer's judgment.
Polysomnography, the electrophysiological measurement of sleep, is widely used in the clinical setting to diagnose sleep disorders. Using this more objective measure, Masel and colleagues (2001) found a high prevalence of posttraumatic hypersomnia, sleep apnea-hypopnea syndrome and periodic limb movement disorder that was not identified through self-report measures (Masel, Scheibel, Kimbark, \& Kuna, 2001). This illustrates the limitations of self-report questionnaires and highlights the need for more objective measures. However, the high cost and inconvenience of polysomnography, requiring multiple electrodes attached to the face, head, and other parts of the body, make it less practical for research studies.
These limitations of subjective self-report measures and the cost and inconvenience of polysomnography suggest the need for alternative methods of measurement. With the use of an actigraph, a small, highly sensitive, accelerometer (motion detector) worn on the wrist over a period of days, a number of sleep-related variables can be derived through the analysis of motion and rest patterns using a computer algorithm (Coffield \& Tryon, 2004). Variables such as sleep latency, total time asleep, and number of nocturnal awakenings derived through actigraphy are comparable to those obtained via polysomnography, and recent research studies demonstrate the validity of actigraph-based sleep/wake estimates among individuals with acquired brain injury (Muller, Czymmek, Thone-Otto, \& Von Cramon, 2006; Tweedy \& Trost, 2005; Schuiling, Rinkel, Walchenbach, \& de Weerd, 2005). Thus, actigraphy represents a means of measurement that will enable the collection of objective data in the comfort of the sleeper's usual environment in a manner that is less invasive and more cost-effective than polysomnography, and more reliable than self-report measures alone.
The most widely researched treatments for sleep disturbance are problematic for individuals with TBI due to their effects on cognition and risk for dependence. With a high prevalence of sleep/wake disorders found among individuals with TBI, Rozerem is a promising treatment option to improve sleep quality that is less likely to exacerbate cognitive sequelae of TBI and less likely to result in dependence.
- Conditions
- Insomnia, Brain Injury
- Being tested
- Ramelteon, Placebo
- Keywords
- sleep disorders, traumatic brain injury
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Brain Injuries, Sleep Wake Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
8mg capsule taken within one half hour of bedtime each night over the three night study period.
PlaceboDietary supplement
Also called sugar pill
Control treatment
| Study group | Role | What they receive |
|---|---|---|
| Rozerem (Ramelteon) | Experimental | The primary drug of interest is a melatonin agonist for the treatment of insomnia. Receives: Drug: Ramelteon |
| Sugar pill | Placebo comparator | Control condition. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep Latency (the number of minutes it takes for the participant to fall asleep after getting into bed), and Total Sleep Time (number of minutes asleep between getting into bed for the night and getting out of bed in the morning).
Measured: At third week of treatment
Secondary outcomes (2)
Epworth Sleepiness Scale
Measure of subjective daytime sleepiness.
Measured: After completing two weeks of treatment
Cognitive Performance
Performance on a computer-administered continuous performance test.
Measured: After completing two weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Lequerica, Kessler Foundation
- Investigators
- Anthony Lequerica, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207050
- Sponsor's protocol ID
- D-604-08
- Other IDs
- 10-3222-BIR-E-0
- Status last verified
- Sep 2014
- First submitted
- 21 Sep 2010
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Banos JH, LaGory J, Sawrie S, Faught E, Knowlton R, Prasad A, Kuzniecky R, Martin RC. Self-report of cognitive abilities in temporal lobe epilepsy: cognitive, psychosocial, and emotional factors. Epilepsy Behav. 2004 Aug;5(4):575-9. doi: 10.1016/j.yebeh.2004.04.010.
PubMed 15256196Fleming JM, Strong J, Ashton R. Self-awareness of deficits in adults with traumatic brain injury: how best to measure? Brain Inj. 1996 Jan;10(1):1-15. doi: 10.1080/026990596124674.
PubMed 8680388Vanderploeg RD, Belanger HG, Duchnick JD, Curtiss G. Awareness problems following moderate to severe traumatic brain injury: Prevalence, assessment methods, and injury correlates. J Rehabil Res Dev. 2007;44(7):937-50. doi: 10.1682/jrrd.2006.12.0163.
PubMed 18075951Burke DT, Shah MK, Schneider JC, Ahangar B, Al Aladai S. Sleep-wake patterns in brain injury patients in an acute inpatient rehabilitation hospital setting. The Journal of Applied Research 4(2):239-244, 2004.
Worthington AD, Melia Y. Rehabilitation is compromised by arousal and sleep disorders: results of a survey of rehabilitation centres. Brain Inj. 2006 Mar;20(3):327-32. doi: 10.1080/02699050500488249.
PubMed 16537274Masel BE, Scheibel RS, Kimbark T, Kuna ST. Excessive daytime sleepiness in adults with brain injuries. Arch Phys Med Rehabil. 2001 Nov;82(11):1526-32. doi: 10.1053/apmr.2001.26093.
PubMed 11689971Coffield TG, Tryon WW. Construct validation of actigraphic sleep measures in hospitalized depressed patients. Behav Sleep Med. 2004;2(1):24-40. doi: 10.1207/s15402010bsm0201_3.
PubMed 15600222Muller U, Czymmek J, Thone-Otto A, Von Cramon DY. Reduced daytime activity in patients with acquired brain damage and apathy: a study with ambulatory actigraphy. Brain Inj. 2006 Feb;20(2):157-60. doi: 10.1080/02699050500443467.
PubMed 16421064Schuiling WJ, Rinkel GJ, Walchenbach R, de Weerd AW. Disorders of sleep and wake in patients after subarachnoid hemorrhage. Stroke. 2005 Mar;36(3):578-82. doi: 10.1161/01.STR.0000154862.33213.73. Epub 2005 Jan 27.
PubMed 15677579Tweedy SM, Trost SG. Validity of accelerometry for measurement of activity in people with brain injury. Med Sci Sports Exerc. 2005 Sep;37(9):1474-80. doi: 10.1249/01.mss.0000177584.43330.ae.
PubMed 16177597
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Effect of Rozerem on Sleep Disturbance After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01207050
- Acronym / sponsor ID
- D-604-08
- Conditions
- Insomnia, Brain Injury
- Keywords
- sleep disorders, traumatic brain injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 Sep 2010 (estimated)
- 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.
This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.
Detailed description
Although research has begun to examine sleep quality within the traumatic brain injury (TBI) population, most of the studies found in the research literature utilize subjective, self-report measures that can be problematic in terms of response accuracy when used with populations that have known cognitive deficits (Baños, LaGory, Sawrie, Faught, Knowlton, Prasad, Kuzniecky and Martin, 2004). Because TBI often results in a diminished capacity for self-reflective awareness, obtaining reliable sleep-related information is difficult to do through surveys alone (Fleming, Strong, Ashton, 1996; Vanderploeg, Belanger, Duchnick, and Curtiss, 2007).
A number of studies have attempted to objectify the measurement of sleep quality in TBI rehabilitation by having nursing staff keep an overnight log to document whether the patient was asleep or awake at hourly intervals (Burke, Shah, Schneider, Ahangar, \& Al Aladai, 2004; Worthington \& Melia, 2006). Because this results in only one single observation point per hour, it misses the nuances of the sleep/wake cycle obtained through more continuous measurement throughout the night and is still somewhat subjective and dependent on the observer's judgment.
Polysomnography, the electrophysiological measurement of sleep, is widely used in the clinical setting to diagnose sleep disorders. Using this more objective measure, Masel and colleagues (2001) found a high prevalence of posttraumatic hypersomnia, sleep apnea-hypopnea syndrome and periodic limb movement disorder that was not identified through self-report measures (Masel, Scheibel, Kimbark, \& Kuna, 2001). This illustrates the limitations of self-report questionnaires and highlights the need for more objective measures. However, the high cost and inconvenience of polysomnography, requiring multiple electrodes attached to the face, head, and other parts of the body, make it less practical for research studies.
These limitations of subjective self-report measures and the cost and inconvenience of polysomnography suggest the need for alternative methods of measurement. With the use of an actigraph, a small, highly sensitive, accelerometer (motion detector) worn on the wrist over a period of days, a number of sleep-related variables can be derived through the analysis of motion and rest patterns using a computer algorithm (Coffield \& Tryon, 2004). Variables such as sleep latency, total time asleep, and number of nocturnal awakenings derived through actigraphy are comparable to those obtained via polysomnography, and recent research studies demonstrate the validity of actigraph-based sleep/wake estimates among individuals with acquired brain injury (Muller, Czymmek, Thone-Otto, \& Von Cramon, 2006; Tweedy \& Trost, 2005; Schuiling, Rinkel, Walchenbach, \& de Weerd, 2005). Thus, actigraphy represents a means of measurement that will enable the collection of objective data in the comfort of the sleeper's usual environment in a manner that is less invasive and more cost-effective than polysomnography, and more reliable than self-report measures alone.
The most widely researched treatments for sleep disturbance are problematic for individuals with TBI due to their effects on cognition and risk for dependence. With a high prevalence of sleep/wake disorders found among individuals with TBI, Rozerem is a promising treatment option to improve sleep quality that is less likely to exacerbate cognitive sequelae of TBI and less likely to result in dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rozerem (Ramelteon) | Experimental | Drug: RamelteonThe primary drug of interest is a melatonin agonist for the treatment of insomnia. |
| Sugar pill | Placebo comparator | Dietary Supplement: PlaceboControl condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- History of traumatic brain injury (TBI) as determined by any of the following at least 1 month prior to study entry:
- Endorsement of any of the following by self-report or proxy-report:
- Typical bedtime between 8pm and midnight with wake-up time between 6am and 10am on weekdays.
- Must be living in the community
- In the opinion of the Study Team, the participant must be deemed reliable and likely to make all study visits
Key exclusion criteria (9 listed)
- Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the actigraph
- Individuals using other known hypnotic agents (i.e., benzodiazepines, diphenhydramine, zolpidem) will be considered for participation but must have refrained from using sleep medication for two weeks prior to the study and throughout the course of the study
- Movement disorder or spasticity affecting both upper extremities
- Severe pain or history of chronic pain
- Individuals with multiple musculoskeletal injuries
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 |
|---|---|---|
| RamelteonAlso: Rozerem8mg capsule taken within one half hour of bedtime each night over the three night study period. | Drug | Rozerem (Ramelteon) |
| PlaceboAlso: sugar pillControl treatment | Dietary supplement | Sugar pill |
Primary outcome
Sleep Quality
Time frame: At third week of treatment
Sleep Latency (the number of minutes it takes for the participant to fall asleep after getting into bed), and Total Sleep Time (number of minutes asleep between getting into bed for the night and getting out of bed in the morning).
2 secondary outcomes
Epworth Sleepiness Scale
Time frame: After completing two weeks of treatment
Cognitive Performance
Time frame: After completing two weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- Background: PubMed 15256196Banos JH, LaGory J, Sawrie S, Faught E, Knowlton R, Prasad A, Kuzniecky R, Martin RC. Self-report of cognitive abilities in temporal lobe epilepsy: cognitive, psychosocial, and emotional factors. Epilepsy Behav. 2004 Aug;5(4):575-9. doi: 10.1016/j.yebeh.2004.04.010.
- Background: PubMed 8680388Fleming JM, Strong J, Ashton R. Self-awareness of deficits in adults with traumatic brain injury: how best to measure? Brain Inj. 1996 Jan;10(1):1-15. doi: 10.1080/026990596124674.
- Background: PubMed 18075951Vanderploeg RD, Belanger HG, Duchnick JD, Curtiss G. Awareness problems following moderate to severe traumatic brain injury: Prevalence, assessment methods, and injury correlates. J Rehabil Res Dev. 2007;44(7):937-50. doi: 10.1682/jrrd.2006.12.0163.
- BackgroundBurke DT, Shah MK, Schneider JC, Ahangar B, Al Aladai S. Sleep-wake patterns in brain injury patients in an acute inpatient rehabilitation hospital setting. The Journal of Applied Research 4(2):239-244, 2004.
- Background: PubMed 16537274Worthington AD, Melia Y. Rehabilitation is compromised by arousal and sleep disorders: results of a survey of rehabilitation centres. Brain Inj. 2006 Mar;20(3):327-32. doi: 10.1080/02699050500488249.
- Background: PubMed 11689971Masel BE, Scheibel RS, Kimbark T, Kuna ST. Excessive daytime sleepiness in adults with brain injuries. Arch Phys Med Rehabil. 2001 Nov;82(11):1526-32. doi: 10.1053/apmr.2001.26093.
- Background: PubMed 15600222Coffield TG, Tryon WW. Construct validation of actigraphic sleep measures in hospitalized depressed patients. Behav Sleep Med. 2004;2(1):24-40. doi: 10.1207/s15402010bsm0201_3.
- Background: PubMed 16421064Muller U, Czymmek J, Thone-Otto A, Von Cramon DY. Reduced daytime activity in patients with acquired brain damage and apathy: a study with ambulatory actigraphy. Brain Inj. 2006 Feb;20(2):157-60. doi: 10.1080/02699050500443467.
- Background: PubMed 15677579Schuiling WJ, Rinkel GJ, Walchenbach R, de Weerd AW. Disorders of sleep and wake in patients after subarachnoid hemorrhage. Stroke. 2005 Mar;36(3):578-82. doi: 10.1161/01.STR.0000154862.33213.73. Epub 2005 Jan 27.
- Background: PubMed 16177597Tweedy SM, Trost SG. Validity of accelerometry for measurement of activity in people with brain injury. Med Sci Sports Exerc. 2005 Sep;37(9):1474-80. doi: 10.1249/01.mss.0000177584.43330.ae.
- Click here for further information about this studyLink provided by the sponsor.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Anthony Lequerica, PhD principal investigator
Kessler Foundation
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 Ramelteon in people with Insomnia and Brain Injury, run by Kessler Foundation at 1 site in United States.
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 14 inclusion and 9 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 9 Sep 2014. 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 States. 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. 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.
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?
Results are not available in the source record.
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?
Sleep Quality (time frame: At third week of treatment). 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 NCT01207050, which also lists 10 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 9 Sep 2014.