Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

University of Calgary

Status

Active, not recruiting

Conditions

Obstructive Sleep Apnea

Treatments

Other: Early Management

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04613414

REB20-1667

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)