Traumatic Brain Injury Clinical Trial
Official title:
Open-label Clinical Trial to Evaluate the Efficacy of Sodium Oxybate (Xyrem®) in the Treatment of Two Under-recognized Clinical Conditions: Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
Verified date | March 2021 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates whether the use of Sodium Oxybate (Xyrem®) in TBI patients will be effective in reducing symptoms of post traumatic narcolepsy and post traumatic hypersomnia.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - History of first-ever primary TBI 12 or more months ago; - Mild to severe TBI (GCS 3-15); - Either a) or b): 1. Presence of subjective daytime sleepiness (ESS = 10) lasting 3 months or more, and not present prior to the TBI; 2. Long sleep duration (mean TST = 9hours/24hrs or increased sleep need of at least 1-2 h per 24 h compared to pre-TBI), documented by actigraphy, lasting 3 months or more; - Objectively demonstrated EDS (MSLT mean of 5 naps: SL = 8min); - Age: 18 - 64; - Ability to read and understand consent form, complete questionnaires and daily sleep diary, and provide informed consent. The Folstein MMSE will be used to assess cognitive function. Exclusion Criteria: - Current neurologic deficit (weakness, dysarthria or dysphagia, aphasia or dysphasia); Participants with a score of <27 on Folstein MMSE will be excluded. - History of neurologic or psychiatric disease prior to TBI; - Epilepsy or history of seizure (whether related or unrelated to TBI); - Body mass index (BMI) = 32; - Sleep apnea (Apnea Hypopnea Index, AHI > 15/h); -Chronic sleep restriction (= 2hour sleep extension on weekends from self- report, diary, or at least 14 days of actigraphy); - Sleep-wake disturbance other than long sleep duration or sleepiness (DSPD, ASPD, Shift-work Sleep Disorder); - Diagnosis of narcolepsy or other sleep disorder prior to TBI; - Unwillingness to follow physician instructions relating to the concomitant use of alcohol and sodium oxybate during the study; - History of or current substance abuse; - Current regular CNS-affecting medication use; - History of depression, suicidal thoughts, and/or post-traumatic stress disorder (PTSD); - Current depression assessed by a structured clinical interview and Beck Depression Inventory (BDI); - Abnormal liver function (LFT more than twice the upper limit of normal or serum bilirubin more than 1.5 times the upper limit of normal); - Hypertension, heart failure, history of myocardial infarction, or abnormal EKG demonstrating clinically significant arrhythmia; - Kidney disease (Serum creatinine >2.0mg/dl); - Lung disease (COPD, ILD, asthma); - On a low salt diet for medical reasons; - An occupation that requires variable shift work or routine night shifts (work hours between 11pm and 6am); - Pregnant, intention to become pregnant; - Breast-feeding or plans to breastfeed; - Succinic semialdehyde dehydrogenase deficiency. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Subjective Daytime Sleepiness | Change in subjective daytime sleepiness assessed through a daily questionnaire about frequency and duration of daytime naps, frequency of sleep attacks. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Primary | Change in Sleep Duration | Change in sleep duration assessed by actigraphy-estimated total sleep time (TST). | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Primary | Change in Clinical Condition | Change in clinical condition as assessed by Clinical Global Impression (CGI) assessment. CGI assesses a clinician's view of a patient's global functioning before and after initiating medication. It is broken up into CGI-S (Severity) and CGI-I (Improvement). CGI-S is one question assesses how clinically ill a patient is at time of assessment. it is on a 1-7 scale with 1 being normal and 7 being among the most extremely ill patients. CGI-I looks at improvement in patients functioning once medication starts. it is also on a 1-7 scale with 1 being very much improved since initiation of treatment and 7 being very much worse. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Primary | Change in Subjective Daytime Sleepiness (ESS) | Change in daytime sleepiness will be assessed through changes in Epworth Sleepiness Scale (ESS) scores. The ESS measures sleepiness of a participant. It is eight questions with a scale of 0 - 3 with 0 being no chance of dozing and 3 being high chance of dozing. The total score of eight questions is reported. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Nocturnal Sleep Quality (Frequency of nocturnal awakenings) | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of nocturnal awakenings. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Nocturnal Sleep Quality (Duration of nocturnal awakenings) | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on duration of nocturnal awakenings. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Nocturnal Sleep Quality (Subjective amount of sleep) | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on subjective amount of sleep each night. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Nocturnal Sleep Quality (Frequency of sleep walking) | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of sleep walking. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Nocturnal Sleep Quality (Frequency of hypnagogic hallucinations) | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of hypnagogic hallucinations. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Nocturnal Sleep Quality (Change in Pittsburgh Sleep Quality index) scores) | Average change in nocturnal sleep quality assessed by changes in Pittsburgh Sleep Quality Index (PSQI) scores. The PSQI assesses sleep quality. It is broken down into seven components, with scales from 0 - 3 with 0 being better quality of sleep and 3 being a more poor quality of sleep. The Global PSQI score is taken from the sum of the seven component scores. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Nocturnal Sleep Quality (actigraphy) | Average change in nocturnal sleep quality measured by actigraphy. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | |
Secondary | Change in Global Functioning | Change in global functioning evaluated by the Sheehan Disability Scale (SDS). The SDS assesses functional impairment in three subscales: in work/school, social, and family life. Each is subscale is 1-10 with 1 being no disability/impairment and 10 be extreme disability/impairment. These three subscales are added together to give the global functional impairment score which ranges from 0 being unimpaired to 30 being highly impaired. | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. |
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