Narcolepsy Clinical Trial
Official title:
Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia
The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.
This clinical study is a prospective, single group assessment which will enroll patients who are prescribed a multiple sleep latency test (MSLT) at the Fontana Medical Sleep Center. Patients will be mailed an actigraph and a Dreem 3 system to undergo the following assessments: - 1 initial in-person sleep physician encounter to discuss your sleep symptoms and review the informed consent form - 1 week of actigraphy and Dreem 3 System monitoring. Actigraphy will be continuously monitored for 1 week to log sleep and wake periods. Dreem 3 System will be monitored for the first 5 nights and the last 2 days will be 48-hour continuous monitoring (i.e., day and night). Additionally, we will ask you to log your sleep/wake activity in a sleep diary. - 2 consecutive in-lab sleep studies within a 24-hour period - A few reminder telephone calls for at-home monitoring Patients will have a follow up encounter with a physician after their in-lab visit. If a diagnosis is confirmed and treatment is initiated, the patient will be asked if they want to pursue treatment follow-up for the study. Again, patient will wear the Dreem 3 System and the actigraph during 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48 hour measurement, patients will wear the Dreem 3 system and actigraph (i.e. monitoring day and night). This procedure will occur once treatment is initiated as well as 1 month and 3 months after treatment initiation. Patients will be asked to complete various sleep and quality of life questionnaires throughout the duration of the study. Questionnaires should take approximately 10-15 minutes to complete. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04072380 -
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
|
Phase 2 | |
Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 | |
Completed |
NCT02821715 -
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
|
Phase 2 | |
Completed |
NCT01789398 -
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
|
Phase 3 | |
Completed |
NCT01681121 -
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
|
Phase 2 | |
Completed |
NCT00174174 -
Provigil (Modafinil) Study by Taiwan Biotech Co.
|
N/A | |
Completed |
NCT05059223 -
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
|
Phase 3 | |
Completed |
NCT04923594 -
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
|
Phase 2 | |
Recruiting |
NCT06279247 -
Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
|
||
Completed |
NCT04647903 -
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
|
Phase 1 | |
Completed |
NCT03267303 -
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
|
Phase 2 | |
Completed |
NCT03173378 -
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
|
||
Completed |
NCT05055024 -
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
|
Phase 2 | |
Completed |
NCT01067235 -
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
|
Phase 3 | |
Completed |
NCT00228566 -
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
|
Phase 3 | |
Completed |
NCT00107848 -
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
|
Phase 3 | |
Completed |
NCT00107796 -
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
|
Phase 3 | |
Completed |
NCT00132873 -
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
|
Phase 3 | |
Enrolling by invitation |
NCT05113745 -
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy
|
Phase 3 | |
Suspended |
NCT04419792 -
'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
|