Pascoe Maeve M, Wollet Alex R, De La Cruz Minyety Julianie, Vera Elizabeth, Miller Hope, Celiku Orieta, Leeper Heather, Fernandez Kelly, Reyes Jennifer, Young Demarrius, Acquaye-Mallory Alvina, Adegbesan Kendra, Boris Lisa, Burton Eric, Chambers Claudia P, Choi Anna, Grajkowska Ewa, Kunst Tricia, Levine Jason, Panzer Marissa, Penas-Prado Marta, Pillai Valentina, Polskin Lily, Wu Jing, Gilbert Mark R, Mendoza Tito, King Amanda L, Shuboni-Mulligan Dorela, Armstrong Terri S
Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc, Frederick, Maryland.
Neurooncol Pract. 2024 May 24;11(5):640-651. doi: 10.1093/nop/npae048. eCollection 2024 Oct.
Sleep-wake disturbances are common and disabling in primary brain tumor (PBT) patients but studies exploring longitudinal data are limited. This study investigates the feasibility and relationship between longitudinal patient-reported outcomes (PROs) and physiologic data collected via smart wearables.
Fifty-four PBT patients ≥ 18 years wore Fitbit smart-wearable devices for 4 weeks, which captured physiologic sleep measures (eg, total sleep time, wake after sleep onset [WASO]). They completed PROs (sleep hygiene index, PROMIS sleep-related impairment [SRI] and Sleep Disturbance [SD], Morningness-Eveningness Questionnaire [MEQ]) at baseline and 4 weeks. Smart wearable use feasibility (enrollment/attrition, data missingness), clinical characteristics, test consistency, PROs severity, and relationships between PROs and physiologic sleep measures were assessed.
The majority (72%) wore their Fitbit for the entire study duration with 89% missing < 3 days, no participant withdrawals, and 100% PRO completion. PROMIS SRI/SD and MEQ were all consistent/reliable (Cronbach's alpha 0.74-0.92). Chronotype breakdown showed 39% morning, 56% intermediate, and only 6% evening types. Moderate-severe SD and SRI were reported in 13% and 17% at baseline, and with significant improvement in SD at 4 weeks ( = .014). Fitbit-recorded measures showed a correlation at week 4 between WASO and SD ( = 0.35, = .009) but not with SRI ( = 0.24, = .08).
Collecting sleep data with Fitbits is feasible, PROs are consistent/reliable, > 10% of participants had SD and SRI that improved with smart wearable use, and SD was associated with WASO. The skewed chronotype distribution, risk and impact of sleep fragmentation mechanisms warrant further investigation.
NCT04 669 574.
睡眠-觉醒障碍在原发性脑肿瘤（PBT）患者中很常见且会导致功能障碍，但探索纵向数据的研究有限。本研究调查了通过智能可穿戴设备收集的纵向患者报告结局（PROs）与生理数据之间的可行性及关系。
54名年龄≥18岁的PBT患者佩戴Fitbit智能可穿戴设备4周，该设备可记录生理睡眠指标（如总睡眠时间、睡眠开始后觉醒时间[WASO]）。他们在基线和4周时完成了PROs（睡眠卫生指数、PROMIS睡眠相关损害[SRI]和睡眠障碍[SD]、晨型-夜型问卷[MEQ]）。评估了智能可穿戴设备的使用可行性（入组/失访、数据缺失情况）、临床特征、测试一致性、PROs严重程度以及PROs与生理睡眠指标之间的关系。
大多数（72%）患者在整个研究期间都佩戴了Fitbit，89%的患者数据缺失<3天，无参与者退出，PROs完成率为100%。PROMIS SRI/SD和MEQ均具有一致性/可靠性（Cronbach's α为0.74 - 0.92）。昼夜节律类型分布显示，39%为晨型，56%为中间型，仅6%为夜型。基线时，13%和17%的患者报告有中度至重度SD和SRI，4周时SD有显著改善（P = 0.014）。Fitbit记录的指标显示，第4周时WASO与SD之间存在相关性（r = 0.35，P = 0.009），但与SRI无关（r = 0.24，P = 0.08）。
使用Fitbit收集睡眠数据是可行的，PROs具有一致性/可靠性，超过10%的参与者的SD和SRI因使用智能可穿戴设备而得到改善，且SD与WASO相关。昼夜节律类型分布不均、睡眠片段化机制的风险和影响值得进一步研究。
NCT04 669 574。
