Portable Monitoring for Diagnosis and Management of Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-03-31

Brief Summary

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

This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.

Related Clinical Trials

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

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

Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients

NCT03473548

Sleep Apnea, Obstructive

COMPLETED NA

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

NCT02987283

Sleep Apnea, Obstructive

COMPLETED

Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

NCT01175031

Sleep Apnea Central Cheyne-Stokes Respiration Obstructive Sleep Apnea

COMPLETED NA

A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto - CPAP for Sleep Apnea

NCT00254059

Obstructive Sleep Apnea

COMPLETED NA

Detailed Description

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

The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches \[home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)\] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.

Conditions

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

Sleep Apnea, Obstructive

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

1

laboratory-based testing

Group Type ACTIVE_COMPARATOR

Standard polysomnography (PSG)

Intervention Type OTHER

laboratory-based testing

2

home-based testing

Group Type ACTIVE_COMPARATOR

Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)

Intervention Type OTHER

portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.

Interventions

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

Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)

portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.

Intervention Type OTHER

Standard polysomnography (PSG)

laboratory-based testing

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Intermediate to high probability of having OSA based on an adjusted neck circumference \> 43 cm (17 inches)
* Presence of excessive daytime sleepiness (Epworth sleepiness scale ≥ 12) Apnea-hypopnea index \>= 15 on diagnostic testing to continue in study

Exclusion Criteria

* Severe chronic insomnia, other condition with \< 4 hrs of sleep per night
* Unstable medical conditions
* Major psychiatric diagnosis
* Unable to undergo home testing
* Concerns about unsafe driving
* Severe COPD or restrictive lung disease
* Chronic narcotic use
* Alcohol abuse
* History of cataplexy
* Moderate to severe restless legs syndrome symptoms
* Pre-existing diagnosis of sleep apnea
* Prior experience with positive airway pressure treatment of sleep apnea
* Anticipated upper airway surgery or gastric bypass surgery in 4 months
* Decisional impairment for consenting
* Hypoventilation syndrome, identified in the medical record
* Waking oxygen saturation \< 92%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No