Sleep Medicine

Sleep assessments such as polysomnography (PSG) and actigraphy require highly controlled environments and can vary widely between sites.

iNGENū addresses this pain point with Centralised and Standardised Assessments

We employ centralised sleep laboratories with uniform protocols and extensively trained technicians to ensure consistency across trial sites. Centralised scoring by expert sleep technologists further enhances data accuracy and reliability.

Sleep disorders often show significant placebo effects due to the subjective nature of sleep quality and daytime functioning assessments.

iNGENū addresses this pain point with Rigorous Blinding and Trial Design

We utilise rigorous double-blind methodologies and innovative trial designs, including crossover and placebo run-in periods, to minimise placebo and expectancy effects. Advanced statistical methods further isolate genuine treatment responses from placebo effects.

Evaluating sleep interventions often involves both objective measures (e.g., sleep latency, sleep architecture) and subjective measures (e.g., patient-reported sleep quality, daytime sleepiness).

iNGENū addresses this pain point with Integrated Objective and Subjective Assessments

Our trials are designed to integrate comprehensive objective measurements from PSG and actigraphy with validated subjective patient-reported outcomes (PROMs) such as the Epworth Sleepiness Scale (ESS) and Insomnia Severity Index (ISI). Expert biostatistical analysis ensures precise interpretation of multifaceted data sets.

Identifying and maintaining patient participation in sleep studies can be difficult due to the frequent need for overnight assessments, intrusive monitoring, and stringent eligibility criteria.

iNGENū CRO addresses this pain point with Patient-centric Approaches

We streamline recruitment by collaborating with specialised sleep clinics and employing comprehensive patient databases. Our patient-centric trial designs incorporate home-based and remote monitoring technologies, reducing the burden on patients and enhancing retention rates.

Many sleep interventions involve central nervous system (CNS)-active treatments, which require vigilant safety monitoring due to potential adverse cognitive, behavioural, or respiratory effects.

iNGENū addresses this pain point with Robust Safety Protocols

Our dedicated safety monitoring teams conduct continuous, real-time evaluations of patient safety data. Comprehensive risk management plans and transparent communication with stakeholders ensure swift identification and handling of adverse events, prioritising patient well-being throughout the trial.