Evidence map›Paper›PMID 37380020›Full record

ArticleContemporary clinical trials2023

A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk: Design and methodology of a randomized clinical trial.

Sarah E Emert, Daniel J Taylor, Daniel Gartenberg, Margeaux M Schade, Daniel M Roberts, Samantha M Nagy, Michael Russell, Alisa Huskey, Melissa Mueller, Alyssa Gamaldo and 1 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Sarah E EmertThe University of Arizona, Department of Psychology, Tucson, AZ, United States.
Daniel J TaylorThe University of Arizona, Department of Psychology, Tucson, AZ, United States. Electronic address: danieljtaylor@arizona.edu.
Daniel GartenbergProactive Life, Inc. (DBA SleepSpace), New York, NY, United States.
Margeaux M SchadeThe Pennsylvania State University, Department of Biobehavioral Health, University Park, PA, United States.
Daniel M RobertsProactive Life, Inc. (DBA SleepSpace), New York, NY, United States; The Pennsylvania State University, Department of Biobehavioral Health, University Park, PA, United States.
Samantha M NagyThe University of Arizona, Department of Psychology, Tucson, AZ, United States.
Michael RussellThe Pennsylvania State University, Department of Biobehavioral Health, University Park, PA, United States.
Alisa HuskeyThe University of Arizona, Department of Psychology, Tucson, AZ, United States.
Melissa MuellerProactive Life, Inc. (DBA SleepSpace), New York, NY, United States.
Alyssa GamaldoThe Pennsylvania State University, Department of Biobehavioral Health, University Park, PA, United States.
Orfeu M BuxtonThe Pennsylvania State University, Department of Biobehavioral Health, University Park, PA, United States.
Pennsylvania State University · USUniversity of Arizona · US

Funding

Penn State Clinical and Translational Science InstituteUL1TR002014 · NCATS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KRASCHNEWSKI, JENNIFER L. · 2016 to 2025
$33.7M
Ambulatory Methods for Measuring Cognitive ChangeU2CAG060408 · NIA · PENNSYLVANIA STATE UNIVERSITY, THE · PI SLIWINSKI, MARTIN J · 2018 to 2022
$14.9M
Business and regulatory development for Integrating sleep enhancement technology into clinical practiceR44AG056250 · NIA · PROACTIVE LIFE, INC. · PI GARTENBERG, DANIEL · 2020 to 2022
$2.5M
Non-pharmacological improvement of sleep structure in older peopleR43AG056250 · NIA · MOBILE SLEEP TECHNOLOGIES, LLC · PI GARTENBERG, DANIEL, GERASHCHENKO, DMITRY · 2017 to 2018
$696k
NCATS NIH HHS UL1 TR002014NIA NIH HHS R43 AG056250NIA NIH HHS R44 AG056250NIA NIH HHS U2C AG060408
6 · The paper itself

Abstract

Aging populations are at increased risk of sleep deficiencies (e.g., insomnia) that are associated with a variety of chronic health risks, including Alzheimer's disease and related dementias (ADRD). Insomnia medications carry additional risk, including increased drowsiness and falls, as well as polypharmacy risks. The recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi), but access is limited. Telehealth is one way to increase access, particularly for older adults, but to date telehealth has been typically limited to simple videoconferencing portals. While these portals have been shown to be non-inferior to in-person treatment, it is plausible that telehealth could be significantly improved. This work describes a protocol designed to evaluate whether a clinician-patient dashboard inclusive of several user-friendly features (e.g., patterns of sleep data from ambulatory devices, guided relaxation resources, and reminders to complete in-home CBTi practice) could improve CBTi outcomes for middle- to older-aged adults (N = 100). Participants were randomly assigned to one of three telehealth interventions delivered through 6-weekly sessions: (1) CBTi augmented with a clinician-patient dashboard, smartphone application, and integrated smart devices; (2) standard CBTi (i.e., active comparator); or (3) sleep hygiene education (i.e., active control). All participants were assessed at screening, pre-study evaluation, baseline, throughout treatment, and at 1-week post-treatment. The primary outcome is the Insomnia Severity Index. Secondary and exploratory outcomes span sleep diary, actiwatch and Apple watch assessed sleep parameters (e.g., efficiency, duration, timing, variability), psychosocial correlates (e.g., fatigue, depression, stress), cognitive performance, treatment adherence, and neurodegenerative and systemic inflammatory biomarkers.

Indexed as

Cognitive DysfunctionSleep Initiation and Maintenance DisordersAdultAgedCognitionHumansMiddle AgedRandomized Controlled Trials as TopicSleepTreatment OutcomeCognitive behavioral therapyInsomnia disorderInternet of thingsmHealthSleep hygieneTreatment

Identifiers

PMID37380020
PMCPMC11972623
OpenAlexW4382051663

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.