Is My Sleep Tracker Tracking my Sleep?

NCT06174558 | Unknown

• 1 other identifier: THIRB-RespiratorySpecialists
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to collect health and physiological data using commercially available wristband fitness tracker devices (FitBit and Garmin devices) to help determine their accuracy and reliability at measuring percent of night spent in REM sleep, oxygen desaturation, and apnea hypopnea index compared with currently available methods of in-laboratory polysomnogram and home sleep testing.

Conditions

Obstructive Sleep Apnea

Keywords

Wearable Device; Smartwatch; PSG; Polysomnogram; Home Sleep Test; Oxygen Monitoring; Sleep Staging; Sleep Duration; Breathing Quality; OSA; Obstructive Sleep Apnea; Respiratory Medicine; Sleep Medicine; Oximetry; REM Sleep; Alice NightOne; FitBit Inspire; Garmin Vivosmart; Oxygen Desaturation; Apnea Hypopnea Index; AHI

Outcome Measures

Primary Outcomes (1)

• Monitoring of Sleep Staging

  Percent of the night spent in REM sleep recorded in each device

  Throughout study completion, approximately 5 months

Secondary Outcomes (1)

• Oxygen Desaturation

  Throughout study completion, approximately 5 months

Other Outcomes (1)

• Apnea Hypopnea Index

  Throughout study completion, approximately 5 months

Study Arms (1)

Patients referred to Sleep Health Center for diagnostic PSG

Prospective obstructive sleep apnea patients referred for diagnostic overnight polysomnogram test

Device: Sleep Tracking Devices

Interventions

Sleep Tracking Devices DEVICE

Observational Study, Smartwatches and home sleep device for sleep and respiratory monitoring

Also known as: Garmin Vivosmart 5, FitBit Inspire 3, Alice NightOne Level 3 Home Study

Patients referred to Sleep Health Center for diagnostic PSG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recently ordered for diagnostic polysomnogram.

You may qualify if:

• Age 18 or over
• Able to read and understand the informed consent document, and provide written consent.
• Referred to the Sleep Health Center for diagnostic polysomnogram.
• Agrees to complete standard Sleep Health Center questionnaires.
• Agrees to wear, in addition to standard polysomnogram equipment/leads, the GVS5 tracker, the FBI3 tracker, and the Alice NightOne Level 3 sleep study equipment.
• Agrees to permit review of fitness/sleep tracker physiologic data (for the study night, only) and Alice NightOne Level 3 sleep study and polysomnogram data.
• Agrees to provide review of specified demographic and clinical data, review of polysomnogram data and completion of study questionnaire data, to be stored in de-identified form.
• Undergo diagnostic polysomnogram.

You may not qualify if:

• Current atrial fibrillation (remote history of atrial fibrillation, but now in sinus rhythm, will not be excluded)
• Permanent pacemaker
• Chronic hypoxic respiratory failure, requiring supplemental oxygen.
• Multiple sleep latency testing or split-night polysomnogram testing.
• Inability to provide, or declines to provide, informed, written consent.
• Tattoos over the wrist/forearm that would preclude accurate measurement of fitness tracker variables.
• Anatomic injury or disability that would preclude wearing the tracker on the nondominant wrist (including injury, cast, etc.).

Sponsors & Collaborators

• Respiratory Specialists: lead
• The Reading Hospital and Medical Center: collaborator

Study Sites (1)

Respiratory Specialists

Wyomissing, Pennsylvania, 19610, United States

Location

Related Publications (19)

• de Zambotti M, Cellini N, Goldstone A, Colrain IM, Baker FC. Wearable Sleep Technology in Clinical and Research Settings. Med Sci Sports Exerc. 2019 Jul;51(7):1538-1557. doi: 10.1249/MSS.0000000000001947.

  PMID: 30789439 BACKGROUND

• Grandner MA, Lujan MR, Ghani SB. Sleep-tracking technology in scientific research: looking to the future. Sleep. 2021 May 14;44(5):zsab071. doi: 10.1093/sleep/zsab071. No abstract available.

  PMID: 33782687 BACKGROUND

• Lee XK, Chee NIYN, Ong JL, Teo TB, van Rijn E, Lo JC, Chee MWL. Validation of a Consumer Sleep Wearable Device With Actigraphy and Polysomnography in Adolescents Across Sleep Opportunity Manipulations. J Clin Sleep Med. 2019 Sep 15;15(9):1337-1346. doi: 10.5664/jcsm.7932.

  PMID: 31538605 BACKGROUND

• Lim SE, Kim HS, Lee SW, Bae KH, Baek YH. Validation of Fitbit Inspire 2TM Against Polysomnography in Adults Considering Adaptation for Use. Nat Sci Sleep. 2023 Feb 28;15:59-67. doi: 10.2147/NSS.S391802. eCollection 2023.

  PMID: 36879665 BACKGROUND

• Klier K, Wagner M. Agreement of Sleep Measures-A Comparison between a Sleep Diary and Three Consumer Wearable Devices. Sensors (Basel). 2022 Aug 18;22(16):6189. doi: 10.3390/s22166189.

  PMID: 36015949 BACKGROUND

• Miller DJ, Sargent C, Roach GD. A Validation of Six Wearable Devices for Estimating Sleep, Heart Rate and Heart Rate Variability in Healthy Adults. Sensors (Basel). 2022 Aug 22;22(16):6317. doi: 10.3390/s22166317.

  PMID: 36016077 BACKGROUND

• Lee YJ, Lee JY, Cho JH, Choi JH. Interrater reliability of sleep stage scoring: a meta-analysis. J Clin Sleep Med. 2022 Jan 1;18(1):193-202. doi: 10.5664/jcsm.9538.

  PMID: 34310277 BACKGROUND

• Nikkonen S, Somaskandhan P, Korkalainen H, Kainulainen S, Terrill PI, Gretarsdottir H, Sigurdardottir S, Olafsdottir KA, Islind AS, Oskarsdottir M, Arnardottir ES, Leppanen T. Multicentre sleep-stage scoring agreement in the Sleep Revolution project. J Sleep Res. 2024 Feb;33(1):e13956. doi: 10.1111/jsr.13956. Epub 2023 Jun 13.

  PMID: 37309714 BACKGROUND

• Younes M, Kuna ST, Pack AI, Walsh JK, Kushida CA, Staley B, Pien GW. Reliability of the American Academy of Sleep Medicine Rules for Assessing Sleep Depth in Clinical Practice. J Clin Sleep Med. 2018 Feb 15;14(2):205-213. doi: 10.5664/jcsm.6934.

  PMID: 29351821 BACKGROUND

• Kuna ST, Gurubhagavatula I, Maislin G, Hin S, Hartwig KC, McCloskey S, Hachadoorian R, Hurley S, Gupta R, Staley B, Atwood CW. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. 2011 May 1;183(9):1238-44. doi: 10.1164/rccm.201011-1770OC. Epub 2011 Jan 21.

  PMID: 21471093 BACKGROUND

• Santos-Silva R, Sartori DE, Truksinas V, Truksinas E, Alonso FF, Tufik S, Bittencourt LR. Validation of a portable monitoring system for the diagnosis of obstructive sleep apnea syndrome. Sleep. 2009 May;32(5):629-36. doi: 10.1093/sleep/32.5.629.

  PMID: 19480230 BACKGROUND

• Scalzitti N, Hansen S, Maturo S, Lospinoso J, O'Connor P. Comparison of home sleep apnea testing versus laboratory polysomnography for the diagnosis of obstructive sleep apnea in children. Int J Pediatr Otorhinolaryngol. 2017 Sep;100:44-51. doi: 10.1016/j.ijporl.2017.06.013. Epub 2017 Jun 16.

  PMID: 28802385 BACKGROUND

• Watkins MR, Talmage JB, Thiese MS, Hudson TB, Hegmann KT. Correlation between screening for obstructive sleep apnea using a portable device versus polysomnography testing in a commercial driving population. J Occup Environ Med. 2009 Oct;51(10):1145-50. doi: 10.1097/JOM.0b013e3181b68d52.

  PMID: 19786903 BACKGROUND

• Zhao YY, Weng J, Mobley DR, Wang R, Kwon Y, Zee PC, Lutsey PL, Redline S. Effect of Manual Editing of Total Recording Time: Implications for Home Sleep Apnea Testing. J Clin Sleep Med. 2017 Jan 15;13(1):121-126. doi: 10.5664/jcsm.6404.

  PMID: 27707441 BACKGROUND

• Gurubhagavatula I, Fields BG, Morales CR, Hurley S, Pien GW, Wick LC, Staley BA, Townsend RR, Maislin G. Screening for severe obstructive sleep apnea syndrome in hypertensive outpatients. J Clin Hypertens (Greenwich). 2013 Apr;15(4):279-88. doi: 10.1111/jch.12073. Epub 2013 Feb 12.

  PMID: 23551728 BACKGROUND

• Miller JN, Kupzyk KA, Zimmerman L, Pozehl B, Schulz P, Romberger D, Berger AM. Comparisons of measures used to screen for obstructive sleep apnea in patients referred to a sleep clinic. Sleep Med. 2018 Nov;51:15-21. doi: 10.1016/j.sleep.2018.06.007. Epub 2018 Jun 28.

  PMID: 30077956 BACKGROUND

• Lapin BR, Bena JF, Walia HK, Moul DE. The Epworth Sleepiness Scale: Validation of One-Dimensional Factor Structure in a Large Clinical Sample. J Clin Sleep Med. 2018 Aug 15;14(8):1293-1301. doi: 10.5664/jcsm.7258.

  PMID: 30092893 BACKGROUND

• Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.

  PMID: 26163057 BACKGROUND

• Harrison EI, Roth RH, Lobo JM, Kang H, Logan J, Patel SR, Kapur VK, Kwon Y. Sleep time and efficiency in patients undergoing laboratory-based polysomnography. J Clin Sleep Med. 2021 Aug 1;17(8):1591-1598. doi: 10.5664/jcsm.9252.

  PMID: 33739259 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Alec Platt, MD

  Respiratory Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alec Platt, MD

CONTACT

6106855864; aplatt@lungmd.net

Eric Abreu, MPH

CONTACT

6106855864; eabreu@lungmd.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

US (1)