ANNE Diagnostic Agreement With Home Sleep Testing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-06

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea

NCT04643782

Obstructive Sleep Apnea of Adult

COMPLETED NA

Reiterative Development and Evaluation Study of OSA Therapy System

NCT01634074

Obstructive Sleep Apnea

UNKNOWN

A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test

NCT03049982

Obstructive Sleep Apnea

COMPLETED NA

Evaluating Accuracy of Breath Sound Recordings and STOP-Bang Screening For Obstructive Sleep Apnea While Awake

NCT02987283

Sleep Apnea, Obstructive

COMPLETED

Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea

NCT04778748

Sleep Apnea, Obstructive

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea of Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ANNE Sleep

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

Group Type EXPERIMENTAL

ANNE Sleep

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ANNE Sleep

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No