Global Genes and Sleep Consortium Publish Consensus on Patient-Reported Outcome Measures for Central Disorders of Hypersomnolence

New peer-reviewed paper in SLEEP Advances establishes first consensus framework for measuring what matters most to patients living with rare sleep disorders

WASHINGTON, D.C. March 24, 2026  — Global Genes and Sleep Consortium today announced the publication of a peer-reviewed consensus paper establishing recommended patient-reported outcome measures (PROs) for research into central disorders of hypersomnolence (CDoH), including narcolepsy type 1, narcolepsy type 2, idiopathic hypersomnia, and Kleine-Levin syndrome. The paper, “Patient-reported outcome measures in central disorders of hypersomnolence: consensus of a sleep consortium/RARE-X expert working group” was published in SLEEP Advances, a peer-reviewed journal of the Sleep Research Society.

The publication is a direct outcome of the Sleep Data Collection Initiative, launched in 2023 through a collaboration between RARE-X—the research program of Global Genes—and Sleep Consortium, a nonprofit dedicated to accelerating research and therapy development for CDoH. Led by Global Genes, this paper represents the consensus of a multidisciplinary expert working group convening clinicians, sleep researchers, patient advocates, and industry partners to address a critical gap: the absence of standardized, validated measures that meaningfully capture the lived experience of adults and children living with these rare and often debilitating sleep disorders.

The paper identifies seven recommended patient-reported clinical outcome assessment (COA) measures for adults and six for pediatric patients, selected to capture the most impactful dimensions of CDoH—including sleep disruption, daytime fatigue, cognitive effects, and co-occurring physical and mental health challenges. These consensus-endorsed tools are now deployed within the DREAMS Portal, RARE-X’s patient-owned data collection platform for the CDoH community, generating research-grade real-world evidence to inform drug development and clinical trial design.

“As a parent of a child with narcolepsy and someone who has spent years working to accelerate research for this community, I know how much it matters to measure the patient experience in a meaningful way,” said Lindsay Jesteadt, Co-Founder and CEO of Sleep Consortium and COO of Hypersomnia Foundation. “This consensus gives researchers and drug developers the patient-centered tools they need to design trials that truly matter to people living with narcolepsy, idiopathic hypersomnia, and related disorders. That’s how we move from data to real change in patients’ lives.”

Dr. Lynn Marie Trotti, Director of the Sleep Center and Associate Professor of Neurology at Emory University School of Medicine, who served on the expert working group, agrees: “This consensus is a meaningful step toward standardized clinical trials that reflect the actual lived experience of patients with narcolepsy, idiopathic hypersomnia, and Kleine-Levin syndrome. Utilizing an established set of validated outcome measures will strengthen both the science and the regulatory pathway for new therapies.”

The consensus framework has direct implications for rare disease drug development. Standardized PROs aligned with patient experience provide a pathway for researchers and sponsors to design outcome-driven clinical trials, satisfy regulatory expectations for patient experience data, and build natural history datasets with consistent endpoints—all critical steps toward bringing new therapies to patients with limited or no treatment options.

The full publication is available open access in SLEEP Advances. Patients and caregivers interested in contributing to CDoH research can join the DREAMS Portal at globalgenes.org/sleep-consortium.

About Global Genes
Global Genes is a 501(c)(3) non-profit organization dedicated to eliminating the burdens and challenges of rare diseases for patients, their families and disease communities globally. For nearly two decades, we’ve equipped rare disease patients and advocates with tools, training and support – to connect patients with needed resources, activate communities and advance research. Global Genes serves the more than 400 million people around the globe, and the nearly one in 10 Americans affected by rare diseases. With over 800 patient advocacy group members in our Global Advocacy Alliance, we work with patient advocates, industry partners and academia to build vital ecosystems to progress critical work in rare disease. Learn more at http://www.globalgenes.org.

About RARE-X
RARE-X is the research program of Global Genes. RARE-X provides a highly scalable approach for rare disease data collection, delivered in partnership with patient advocacy groups. RARE-X’s global footprint includes more than 85 disorders from patients in over 90 countries. RARE-X’s innovative, collaborative model is patient-driven with research grade data and is designed to accelerate research and advance urgently needed treatments. Learn more at http://www.globalgenes.org/about-us/about-rare-x/.

About Sleep Consortium
Sleep Consortium is a registered 501(c)(3) nonprofit organization created to accelerate next-generation research, disease understanding, and therapy development for people living with central disorders of hypersomnolence and related diseases. Learn more at sleepconsortium.org.

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