Actigraphy Detects Increased Naps in Narcolepsy Type 1, Fewer With TAK-861 Therapy

A novel nap-detection algorithm can accurately identify daytime naps among patients with narcolepsy type one (NT1), according to study results presented at the 2025 Annual Meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held from June 7 to 11 in Seattle, Washington.

The hallmark symptom of narcolepsy is excessive daytime sleepiness (EDS), which profoundly impacts daily life for patients. A clinically meaningful indicator of EDS is napping behavior, which can be accurately assessed using wrist-worn accelerometers.

Researchers from Takeda Pharmaceuticals developed an actigraphy-based algorithm to detect daytime napping. To derive the nap model, they sourced data from the Multi-Ethnic Study of Atherosclerosis (MESA), which included manually annotated nap data from participants (N=2237) who wore a wrist-worn actigraphy device for 7 days. The algorithm used sleep-wake epochs from activity counts to predict naps, defined as sleep periods lasting 5 minutes or longer between 9:00 AM and 9:00 PM. Predicted naps were compared with manually annotated naps to prune the algorithm.

The researchers used this validated algorithm to assess napping behaviors using data from a non-drug study (ClinicalTrials.gov Identifier: NCT04445129) where the researchers recruited patients with NT1 (n=16) and healthy matched controls (n=16) and a randomized multicenter study (ClinicalTrials.gov Identifier: NCT05687903,) where researchers recruited patients with NT1 (n=112) and assessed the orexin receptor 2-selective agonist TAK-861.

The primary outcome for this analysis was the proportion of nap-free days and total nap duration on napping days among patients with NT1.

Using MESA data, the algorithm had a sensitivity of 86.5% and an F1 area of 84.6%. Significant correlations were observed with napping (r, -0.16; P <.001) and self-reported sleepiness (r, 0.15; P <.001), suggesting that sleepiness was correlated with fewer nap-free days and longer duration naps.

In the noninterventional trial, patients with NT1 had 11.5 fewer nap-free days (P <.001) and they napped for 37.5 more minutes (P <.001) than control individuals during a 4-week period.

In the TAK-861 trial, patients with NT1 who received TAK-861 had more nap-free days and shorter nap durations in a 4-week period, across TAK-861 dose groups (all P <.001) whereas no changes were observed among those who received placebo.

“We developed a highly sensitive and specific actigraphy-based nap-detection algorithm which identified [2] important nap-related findings: increased napping in untreated participants with NT1, and substantially reduced daytime napping in TAK-861-treated participants with NT1,” the researchers concluded.

Disclosure: This research was supported by Takeda Development Center Americas, Inc. Please see the original reference for a full list of disclosures