ANNE Diagnostic Agreement With Home Sleep Testing

Northwestern University

Status: Completed

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Device: ANNE Sleep

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05421754

STU00214445

Details and patient eligibility

About

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).

Full description

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) for the diagnosis of moderate to severe OSA.

Other study objectives include:

• Determining diagnostic yield from multiple nights and better usability compared to current HST in the intended population. This will include all subjects and a focus on olders 65 and older.
• Gathering participant feedback on the use of the sensors and use of the application elicited through focus groups

Enrollment: 38 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 22 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

Exclusion criteria

-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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

ANNE Sleep

Experimental group

Description:

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

Treatment:

Device: ANNE Sleep