Evaluation of an Early Management Strategy for Obstructive 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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-24

Study Completion Date

2025-12-31

Brief Summary

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The primary objective of this study is to evaluate the effect of more timely care for obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy at three months after treatment initiation. The secondary objectives are to determine if earlier care improves the treatment effect of PAP on patient reported sleepiness, quality of life and patient satisfaction. We will also evaluate the impact of shorter wait times on patient engagement in therapy by assessing initial acceptance of PAP therapy, patient activation and self-efficacy with respect to OSA treatment.

The study hypothesis is that the early management strategy will be superior to usual care with respect to the primary outcome of PAP adherence at three months.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Early Management

Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Group Type EXPERIMENTAL

Early Management

Intervention Type OTHER

Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Usual Care

Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early Management

Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HSAT ODI \>= events/hr and ESS 10 - 15 OR
* HSAT ODI 15 - 30 and ESS 15 or lower

Exclusion Criteria

* Severe nocturnal hypoxemia on HSAT (mean oxygen saturation by pulse oximetry (SpO2) ≤ 85%)
* Severe hypersomnolence (Epworth Sleepiness Scale score ≥ 16)
* Employed in safety-critical occupation
* Recent motor vehicle collision reported on screening questionnaire (within one year)
* Severe hypertension requiring ≥ three antihypertensive medications
* Recent admission to hospital due to unstable cardiopulmonary disease (within 30 days)
* Upcoming major surgery (within six months)
* Prior history of OSA treatment
* Significant co-morbid sleep disorder that would interfere with PAP acclimatization and adherence (e.g., severe insomnia, restless leg syndrome)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No