Scoring Hub

CISRE’s Data Management Core provides our investigators and sponsors with immediate access to sleep recordings and prompt sleep study reports. Its versatile IT backbone combines fixed in-lab and mobile domiciliary testing suites to record, score, analyze and archive raw and summary data. Customized software offers robust, secure mechanisms for transmission of sleep recordings and summary data to and from the Scoring Hub from on-site study beds and remote locations across the globe.

An integral component of the CISRE is its Scoring Hub, an AASM-accredited unit with proficiency in scoring and processing polysomnographic data. The Scoring Hub team is led by an ABMS-certified physician in Sleep Medicine, who is responsible for reviewing all studies that have been scored by the team’s staff of Registered Polysomnography Technicians (RPSGTs). At each stage of the scoring process (see below), detailed quality assurance measures are databased. CISRE maintains the highest quality of sleep data acquisition and analysis by providing staff regular Q/A feedback and by conducting complementary interscorer reliability exercises on an ongoing basis.

Scoring Hub Work Flow

IT Infrastructure supports specialized software that facilitates the transfer of polysomnographic data to the scoring hub via various FTP sites. The specialized IT software databases, encrypts, and compresses these data for submission to the scoring hub.

Scoring Hub Data Flow

Study Management

• Questionnaires
• Screening / Recruitment
• Inclusionary / Exclusionary
• Randomization
• Archive and Report Data

Study Management Online Database

Data Collection by Instrument and Event

Instrument	Phone Screen (1)	Visit-1 (Consent) (2)	Visit-3 (Baseline) (3)	Visit-4 (Treatment) (4)	Exit Screen (5)
Phone Screen	Yes
Consent		Yes
H & P		Yes		Yes	Yes
Questionnaires
Sleep Study			Yes	Yes
Randomization				Yes
Sleep Report			Yes	Yes
Participant Survey					Yes

Equipment

Polysomnographic recordings are obtained using EMBLA N7000 acquisition equipment for recording polysomnographic data, including:

• 32 referential channels
• 8 bipolar channels
• Specialized sensors
  • position
  • oximeter
  • airflow
  • respiratory effort
  • snoring

Facility

The CISRE is housed in a state of the art 12,400 square foot facility on the Johns Hopkins Bayview Medical Center campus. The CISRE facilities are comprised of eight private inpatient rooms with personal full-size bathrooms and the capability of monitoring up to 10 subjects simultaneously. Bariatric beds with a weight capacity of up to 1000 lbs are available, if required. Each room has a voice-activated intercom system that allows continuous on-demand communication between subjects and the monitoring staff. High-quality infrared cameras with zooming capability are integrated within the polysomnographic recording. “Through-the wall” access allows intermittent venous blood sampling or drug administration during sleep without disturbing research subjects. In addition to standard PSG studies, a specialized chronobiology suite of five beds is available for specific protocols that require time, light and sound isolation.