Obstructive Sleep ApneaNCT06174558
Is My Sleep Tracker Tracking my Sleep?
An observational study of Obstructive Sleep Apnea, run by Respiratory Specialists at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sleep Tracking Devices
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recently ordered for diagnostic polysomnogram.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
Alec Platt, MD, 610-685-5864 ext. 238, aplatt@lungmd.net
Eric Abreu, MPH, 6106855864 ext. 167, eabreu@lungmd.net
About this study
Official title: Is My Sleep Tracker Tracking my Sleep? Validation of Two Wearable Fitness Sleep Trackers on Sleep Staging and Nocturnal Hypoxemia in Sleep Medicine Patients Referred for Diagnostic Polysomnogram
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.
Read the detailed description
To date, there is an incomplete picture of the reliability of wearable device trackers to depict sleep quantity and sleep staging information. Prior studies have compared various iterations of wearable sleep trackers to the so-called gold standard of PSG, often but not universally in health populations. A number of important observations have been made to date.
- Wearable device trackers overstate total sleep time (TST) and understate wake after sleep onset (WASO), thereby overestimating sleep efficiency. When comparing a dichotomous of sleep/wake categorization, wearable sleep tracker overestimates of sleep time result in high sensitivity for categorizing a given sleep period (a 30 second or one minute "epoch") as "sleep," but as a consequence, there is an attendant drop in specificity, as true "wake" on PSG is more frequently mislabeled as "sleep" on the wearable device.
- Second, wearable sleep trackers, due to technical limitations of inability to correctly categorizing N1 versus N2 sleep, collapse those stages into a combined category of "Light Sleep."
- Third, the raw data, with heart rate data and heart rate variability data which feed into the proprietary wearable device algorithm to assign sleep stage, are not directly available to researchers. Moreover, the wearable device derived data on sleep staging extracted from the device are often provided in one-minute windows (not the 30-second epoch or window used in PSG scoring). Therefore, the so-called "epoch by epoch" comparisons of exported data from the wearable device, compared to the PSG gold standard, have inherent limitations.
- Nonetheless, even with those limitations acknowledged, important correlations between wearable device-derived sleep time, light sleep and REM staging have been established, using so-called epoch by epoch analysis, which however have varied according to the device chosen and population studied.
For the current study, the investigators do not plan to examine an epoch by epoch assessment of sleep staging as a primary analysis, in part due to its inherent limitations consisting of: (a) lack of raw data from device; (b) difficulty matching up epochs due to differences in timing of the so-called "window" of time observed (30 seconds versus one minute); (c) differences in sleep time recording, thus resulting in different denominators of sleep time; (d) poor test-retest or interrater variability for PSG scoring itself, even among expert academic centers performing epoch by epoch analyses of the very same PSG. Instead, the investigators plan to focus on a more clinically accessible and, for the consumer, more relevant question: how well does the amount (or the percentage) of REM sleep and total sleep time estimated by the wearable sleep tracker correlate with a simultaneous sleep study? Secondary analyses will also assess sleep/wake and additional sleep stage comparisons, and assessments of respiratory parameters of oxygen desaturation, and a comparison of wrist tracker device and PSG sleep compared to Level 3 home sleep test derived recording time, in a population of subjects being evaluated for sleep apnea and other sleep disorders. Summary assessments of the sleep variables for the night will be compared to assess the accuracy of the wearable devices and Level 3 home sleep test to polysomnogram. Through the study, the investigators hope to contribute to building a body of evidence assessing the level of accuracy of the latest generation of consumer wearable sleep tracking devices. The investigators plan to use two devices, the FBI3 and the GVS5 fitness activity trackers, for the study, as these devices are among the most recent versions available, are widely used, are highly affordable (models under $150), and provide ease of measurement (as no continuous Bluetooth smartphone connection is needed to collect data).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sleep Tracking Devices
- 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
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Tracking DevicesDevice
Also called Garmin Vivosmart 5, FitBit Inspire 3, Alice NightOne Level 3 Home Study
Observational Study, Smartwatches and home sleep device for sleep and respiratory monitoring
| Study group | Role | What they receive |
|---|---|---|
| Patients referred to Sleep Health Center for diagnostic PSG | Prospective obstructive sleep apnea patients referred for diagnostic overnight polysomnogram test Receives: Device: Sleep Tracking Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of Sleep Staging
Percent of the night spent in REM sleep recorded in each device
Measured: Throughout study completion, approximately 5 months
Secondary outcomes (1)
Oxygen Desaturation
Oximetry data derived from devices
Measured: Throughout study completion, approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respiratory Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- The Reading Hospital and Medical Center
- Responsible party
- Sponsor
- Investigators
- Alec Platt, MD, Principal investigator, Respiratory Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174558
- Sponsor's protocol ID
- THIRB-RespiratorySpecialists
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30789439Grandner 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.
PubMed 33782687Lee 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.
PubMed 31538605Lim 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.
PubMed 36879665Klier 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.
PubMed 36015949Miller 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.
PubMed 36016077Lee 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.
PubMed 34310277Nikkonen 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.
PubMed 37309714Younes 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.
PubMed 29351821Kuna 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.
PubMed 21471093Santos-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.
PubMed 19480230Scalzitti 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.
PubMed 28802385Watkins 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.
PubMed 19786903Zhao 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.
PubMed 27707441Gurubhagavatula 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.
PubMed 23551728
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is My Sleep Tracker Tracking my Sleep? Validation of Two Wearable Fitness Sleep Trackers on Sleep Staging and Nocturnal Hypoxemia in Sleep Medicine Patients Referred for Diagnostic Polysomnogram
- ClinicalTrials.gov ID
- NCT06174558
- Acronym / sponsor ID
- THIRB-RespiratorySpecialists
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Wearable Device, Smartwatch, PSG, Polysomnogram, Home Sleep Test, Oxygen Monitoring, Sleep Staging, Sleep Duration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Respiratory SpecialistsUniversity, hospital or other
- Collaborators
- The Reading Hospital and Medical Center
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To date, there is an incomplete picture of the reliability of wearable device trackers to depict sleep quantity and sleep staging information. Prior studies have compared various iterations of wearable sleep trackers to the so-called gold standard of PSG, often but not universally in health populations. A number of important observations have been made to date.
- Wearable device trackers overstate total sleep time (TST) and understate wake after sleep onset (WASO), thereby overestimating sleep efficiency. When comparing a dichotomous of sleep/wake categorization, wearable sleep tracker overestimates of sleep time result in high sensitivity for categorizing a given sleep period (a 30 second or one minute "epoch") as "sleep," but as a consequence, there is an attendant drop in specificity, as true "wake" on PSG is more frequently mislabeled as "sleep" on the wearable device.
- Second, wearable sleep trackers, due to technical limitations of inability to correctly categorizing N1 versus N2 sleep, collapse those stages into a combined category of "Light Sleep."
- Third, the raw data, with heart rate data and heart rate variability data which feed into the proprietary wearable device algorithm to assign sleep stage, are not directly available to researchers. Moreover, the wearable device derived data on sleep staging extracted from the device are often provided in one-minute windows (not the 30-second epoch or window used in PSG scoring). Therefore, the so-called "epoch by epoch" comparisons of exported data from the wearable device, compared to the PSG gold standard, have inherent limitations.
- Nonetheless, even with those limitations acknowledged, important correlations between wearable device-derived sleep time, light sleep and REM staging have been established, using so-called epoch by epoch analysis, which however have varied according to the device chosen and population studied.
For the current study, the investigators do not plan to examine an epoch by epoch assessment of sleep staging as a primary analysis, in part due to its inherent limitations consisting of: (a) lack of raw data from device; (b) difficulty matching up epochs due to differences in timing of the so-called "window" of time observed (30 seconds versus one minute); (c) differences in sleep time recording, thus resulting in different denominators of sleep time; (d) poor test-retest or interrater variability for PSG scoring itself, even among expert academic centers performing epoch by epoch analyses of the very same PSG. Instead, the investigators plan to focus on a more clinically accessible and, for the consumer, more relevant question: how well does the amount (or the percentage) of REM sleep and total sleep time estimated by the wearable sleep tracker correlate with a simultaneous sleep study? Secondary analyses will also assess sleep/wake and additional sleep stage comparisons, and assessments of respiratory parameters of oxygen desaturation, and a comparison of wrist tracker device and PSG sleep compared to Level 3 home sleep test derived recording time, in a population of subjects being evaluated for sleep apnea and other sleep disorders. Summary assessments of the sleep variables for the night will be compared to assess the accuracy of the wearable devices and Level 3 home sleep test to polysomnogram. Through the study, the investigators hope to contribute to building a body of evidence assessing the level of accuracy of the latest generation of consumer wearable sleep tracking devices. The investigators plan to use two devices, the FBI3 and the GVS5 fitness activity trackers, for the study, as these devices are among the most recent versions available, are widely used, are highly affordable (models under $150), and provide ease of measurement (as no continuous Bluetooth smartphone connection is needed to collect data).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred to Sleep Health Center for diagnostic PSG | – | Device: Sleep Tracking DevicesProspective obstructive sleep apnea patients referred for diagnostic overnight polysomnogram test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recently ordered for diagnostic polysomnogram.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Tracking DevicesAlso: Garmin Vivosmart 5, FitBit Inspire 3, Alice NightOne Level 3 Home StudyObservational Study, Smartwatches and home sleep device for sleep and respiratory monitoring | Device | Patients referred to Sleep Health Center for diagnostic PSG |
Primary outcome
Monitoring of Sleep Staging
Time frame: Throughout study completion, approximately 5 months
Percent of the night spent in REM sleep recorded in each device
1 secondary outcome
Oxygen Desaturation
Time frame: Throughout study completion, approximately 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 30789439de 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.
- Background: PubMed 33782687Grandner 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.
- Background: PubMed 31538605Lee 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.
- Background: PubMed 36879665Lim 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.
- Background: PubMed 36015949Klier 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.
- Background: PubMed 36016077Miller 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.
- Background: PubMed 34310277Lee 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.
- Background: PubMed 37309714Nikkonen 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.
- Background: PubMed 29351821Younes 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.
- Background: PubMed 21471093Kuna 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.
- Background: PubMed 19480230Santos-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.
- Background: PubMed 28802385Scalzitti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alec Platt, MD principal investigator
Respiratory Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Respiratory Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alec Platt, MD (6106855864 ext. 238, aplatt@lungmd.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring of Sleep Staging (time frame: Throughout study completion, approximately 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174558, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.