Therapeutic Expertise
Sleep Medicine
Our sleep medicine team runs trials across insomnia, central hypersomnias and sleep-disordered breathing, combining polysomnography expertise with validated objective and patient-reported endpoints.
Sleep trials depend on standardised polysomnography and validated objective measures (e.g. MSLT/MWT) alongside patient-reported outcomes. We standardise sleep-lab procedures, provide central scoring and design endpoint strategies acceptable to the FDA and EMA.
Addressing common pain points in sleep medicine clinical trials
Polysomnography standardisation
PSG scoring varies between labs and scorers.
We use centralised, blinded PSG scoring and standardised lab procedures.
Objective vs subjective endpoints
Sleep efficacy blends objective measures and subjective reports.
We combine validated objective measures with PROs under a coherent analysis plan.
Placebo response in insomnia
Insomnia trials carry substantial placebo response.
We apply design and run-in strategies to protect assay sensitivity.
Resources
Sleep Medicine clinical trial resources
Advancing Narcolepsy Research — Clinical Trials Insights and Innovations
Design and endpoints in narcolepsy.
Enhancing Clinical Trial Outcomes for Idiopathic Hypersomnia
Trial design in idiopathic hypersomnia.
Menopausal Insomnia Clinical Trials
Endpoint considerations in insomnia.
Evidence & insights
Sleep Medicine white papers
Open-access reports from our physicians and data science teams — free, no sign-in.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Sleep Medicine clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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