ANNE Diagnostic Agreement With Home Sleep Testing

NCT05421754 | Completed Results FDA Device

• 1 other identifier: STU00214445
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST).

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea.

  To determine the percent agreement between the ANNE sleep system to a Home Sleep Test (WatchPAT) for diagnostic performance to positively detect moderate to severe obstructive sleep apnea.. The WatchPAT system and ANNE sleep were worn for a single night together. The ANNE sleep system was additionally analyzed for up to 3 multiple nights and the data from those nights was pooled to compare against WatchPAT system for positively detecting moderate to severe obstructive sleep apnea.

  4 nights

Study Arms (1)

ANNE Sleep

EXPERIMENTAL

After consent, subjects will wear the ANNE Sleep system with HST for 1 night and 3 nights with ANNE sleep system alone.

Device: ANNE Sleep

Interventions

ANNE Sleep DEVICE

ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone.

ANNE Sleep

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old.
• Subjects with suspected OSA based on history and physical. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible.
• Willingness to give written consent and comply with study procedures

You may not qualify if:

• An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection based on the opinion of the investigator, this includes but is not limited to: A. Significant cardiorespiratory disease: patients that are oxygen dependent, previous hospitalization for cardiorespiratory issues, or left ventricular ejection fraction ≤ to 40% B. Respiratory muscle weakness due to a neuromuscular condition C. Awake hypoventilation or suspicion of sleep related hypoventilation D. Chronic opioid medication use E. History of stroke F. History of severe insomnia
• Inability to understand instructions
• Has a skin abnormality that precludes assessment
• Has a history of dementia
• Patients with implanted pacemakers or defibrillators

Sponsors & Collaborators

• Northwestern University: lead
• Sibel Health Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Walter J, Lee JY, Blake S, Kalluri L, Cziraky M, Stanek E, Miller J, Harty BJ, Yu L, Park J, Zhang M, Coughlin S, Serao A, Lee J, Buban A, Bae M, Edel C, Toloui O, Rangel SM, Power T, Xu S. A new wearable diagnostic home sleep testing platform: comparison with available systems and benefits of multinight assessments. J Clin Sleep Med. 2023 May 1;19(5):865-872. doi: 10.5664/jcsm.10432.

  PMID: 36692166 DERIVED

Results Point of Contact

• Title: Shuai Xu
• Organization: Northwestern University

stevexu@northwestern.edu

312-695-8106

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will use ANNE Sleep system with Home Sleep Testing (HST) during one night followed by three subsequent nights with the ANNE Sleep system alone.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 16, 2022
• Study Start: January 6, 2022
• Primary Completion: April 30, 2022
• Study Completion: February 28, 2023
• Last Updated: May 26, 2023
• Results First Posted: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)