SBIR-STTR Award

Neurobehavioral Tool for Assessment of Sleep Structure in Psychiatric Disorders
Award last edited on: 4/12/16

Sponsored Program
SBIR
Awarding Agency
NIH : NIMH
Total Award Amount
$499,770
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Stephane Bibian

Company Information

NeuroWave Systems Inc

2490 Lee Boulevard Suite 300
Cleveland Heights, OH 44118
   (216) 361-1591
   info@neurowavesystems.com
   www.neurowavesystems.com
Location: Single
Congr. District: 11
County: Cuyahoga

Phase I

Contract Number: 1R43MH086985-01A1
Start Date: 6/25/10    Completed: 5/31/12
Phase I year
2010
Phase I Amount
$249,847
The overall goal of this project is to develop a novel neuro-behavioral research/clinical tool (SleepMedic") for quantitative analysis of brainwave (electroencephalogram, EEG) during overnight sleep (to monitor sleep architecture and quality), and during waking hours ( to quantify daytime sleepiness), in patients with psychiatric disorders. SleepMedic" will consist of a number of innovative modules including a novel miniaturized and wearable EEG acquisition/processing hardware (in conformable shapes for more convenient sleep), new signal processing techniques for automatic EEG sleep characterization, novel no-prep electrodes harness for easy sensor attachment, and a highly-quantitative neurobehavioral test of sleepiness. The intention is to develop a device that would enable the patients to self-administer a convenient and reliable sleep study at home over an extended period of time. The major rationale for developing SleepMedic is that psychiatric illnesses, such as depression and anxiety, are strongly associated with disruption to sleep structure including insomnia whose symptoms include abnormalities in sleep onset, sleep maintenance, sleep quality, and next day functioning. However, lack of readily available objective tools assisting the diagnosis and monitoring management of insomnia in these patient populations, especially taken together with the abuse potential of sleep aid medications, has left many afflicted individuals either untreated, under-diagnosed, or overmedicated. SleepMedic will attempt to answer this need by providing the mental health researchers and practitioners with a cost-effective and practical means for convenient and long-term monitoring and clinical management of sleep disruptions, insomnia, and daytime hyper-somnolence. During this Phase I period, all aspects of the device (hardware, algorithm, electrode attachment) will be designed, fabricated, and clinically evaluated in a limited number of sleep studies in normal subjects and psychiatric patients. Phase II will entail comprehensive clinical studies in psychiatric patients to quantify their sleep structure and to track their medication efficacy.

Public Health Relevance:
The neuro-behavioral research/clinical tool that will be developed in this project SleepMedic" will provide the mental health researchers and practitioners with a cost-effective and practical means for convenient and long-term monitoring and clinical management of sleep disruptions, insomnia, and daytime sleepiness that are strongly associated with psychiatric disorders such as depression and anxiety. SleepMedic" will consist of an easily wearable (conformable shape for more convenient sleep), fully-automatic device that can be used by the patient and/or caregiver to study night-time sleep quality and daytime sleepiness over an extended period of time.

Public Health Relevance Statement:
The neuro-behavioral research/clinical tool that will be developed in this project SleepMedic" will provide the mental health researchers and practitioners with a cost-effective and practical means for convenient and long-term monitoring and clinical management of sleep disruptions, insomnia, and daytime sleepiness that are strongly associated with psychiatric disorders such as depression and anxiety. SleepMedic" will consist of an easily wearable (conformable shape for more convenient sleep), fully-automatic device that can be used by the patient and/or caregiver to study night-time sleep quality and daytime sleepiness over an extended period of time.

Project Terms:
Abscission; Algorithms; Anxiety; Anxiety Disorders; Artifacts; Arts; Behavioral Research; Care Givers; Caregivers; Cell Communication and Signaling; Cell Signaling; Clinic; Clinical; Clinical Evaluation; Clinical Management; Clinical Research; Clinical Study; Clinical Testing; Computer Programs; Computer software; Consumption; DIMS; Depressed mood; Depression; Detection; Development; Devices; Diagnosis; Disorders of Initiating and Maintaining Sleep; Drowsiness; Drowsinesses; Drugs; Electrodes; Electroencephalogram; Electronics; Emotional Depression; Evaluation; Exacerbated Insomnia; Excision; Extirpation; Forehead; Goals; Home; Home environment; Hour; Individual; Insomnia; Insomnia Disorder; Intention; Intracellular Communication and Signaling; Investigators; Laboratories; Left; Maintenance; Maintenances; Medication; Mental Depression; Mental Health; Mental Hygiene; Mental disorders; Mental health disorders; Methods; Methods and Techniques; Methods, Other; Monitor; Monitoring, Sleep; Moods; Morphologic artifacts; NREM (non rapid eye movement); Operation; Operative Procedures; Operative Surgical Procedures; Outcome; Output; Paradoxical Sleep; Patients; Performance; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Polysomnography; Process; Programming Languages; Protocol; Protocols documentation; Psychiatric Diagnosis; Psychiatric Disease; Psychiatric Disorder; Psychiatric therapeutic procedure; Psychological Health; REM Sleep; Reaction Time; Records; Removal; Research Personnel; Researchers; Response RT; Response Time; Rhombencephalic Sleep; Risk Factors; Secondary to; Self-Administered; Severities; Shapes; Signal Transduction; Signal Transduction Systems; Signaling; Sleep; Sleep Architecture; Sleep Disorders; Sleep Initiation and Maintenance Disorders; Sleep Stages; Sleep, Fast-Wave; Sleep, REM; Sleeplessness; Software; Somnography; Somnolence; Staging; Structure; Surgical; Surgical Interventions; Surgical Procedure; Surgical Removal; Symptoms; Symptoms of depression; System; System, LOINC Axis 4; Techniques; Technology; Testing; Time; Training; Treatment Efficacy; Unspecified Mental Disorder; analog; base; biological signal transduction; clinical test; computer program/software; computerized; computerized data processing; cost; data processing; depressed; depressive; depressive symptoms; design; designing; dreaming sleep; drug/agent; evaluation/testing; experience; flexibility; human subject; innovate; innovation; innovative; mental illness; miniaturize; neurobehavioral; neurobehavioral test; non rapid eye movement; non-REM; non-rapid eye movement; nonrapid eye movement; novel; onset of sleep; patient population; polysomnographic; psychiatric care; psychiatric therapy; psychiatric treatment; psychological disorder; psychomotor reaction time; public health relevance; rapid eye movement sleep; research clinical testing; resection; sadness; sensor; signal processing; sleep maintenance difficulty; sleep measurement; sleep onset; sleep onset difficulty; sleep polysomnography; sleep problem; surgery; therapeutic efficacy; therapeutically effective; tool; virtual; volunteer

Phase II

Contract Number: 5R43MH086985-02
Start Date: 6/25/10    Completed: 5/31/13
Phase II year
2011
Phase II Amount
$249,923
The overall goal of this project is to develop a novel neuro-behavioral research/clinical tool (SleepMedic"") for quantitative analysis of brainwave (electroencephalogram, EEG) during overnight sleep (to monitor sleep architecture and quality), and during waking hours ( to quantify daytime sleepiness), in patients with psychiatric disorders. SleepMedic"" will consist of a number of innovative modules including a novel miniaturized and wearable EEG acquisition/processing hardware (in conformable shapes for more convenient sleep), new signal processing techniques for automatic EEG sleep characterization, novel no-prep electrodes harness for easy sensor attachment, and a highly-quantitative neurobehavioral test of sleepiness. The intention is to develop a device that would enable the patients to self-administer a convenient and reliable sleep study at home over an extended period of time. The major rationale for developing SleepMedic is that psychiatric illnesses, such as depression and anxiety, are strongly associated with disruption to sleep structure including insomnia whose symptoms include abnormalities in sleep onset, sleep maintenance, sleep quality, and next day functioning. However, lack of readily available objective tools assisting the diagnosis and monitoring management of insomnia in these patient populations, especially taken together with the abuse potential of sleep aid medications, has left many afflicted individuals either untreated, under-diagnosed, or overmedicated. SleepMedic will attempt to answer this need by providing the mental health researchers and practitioners with a cost-effective and practical means for convenient and long-term monitoring and clinical management of sleep disruptions, insomnia, and daytime hyper-somnolence. During this Phase I period, all aspects of the device (hardware, algorithm, electrode attachment) will be designed, fabricated, and clinically evaluated in a limited number of sleep studies in normal subjects and psychiatric patients. Phase II will entail comprehensive clinical studies in psychiatric patients to quantify their sleep structure and to track their medication efficacy.

Public Health Relevance:
The neuro-behavioral research/clinical tool that will be developed in this project SleepMedic"" will provide the mental health researchers and practitioners with a cost-effective and practical means for convenient and long-term monitoring and clinical management of sleep disruptions, insomnia, and daytime sleepiness that are strongly associated with psychiatric disorders such as depression and anxiety. SleepMedic"" will consist of an easily wearable (conformable shape for more convenient sleep), fully-automatic device that can be used by the patient and/or caregiver to study night-time sleep quality and daytime sleepiness over an extended period of time.