N/A
Completed N=435
Remote Diagnosis and Management of Obstructive Sleep Apnea
Sleep Apnea - Obstructive · Cost Effectiveness · Telemedicine
Source: ClinicalTrials.gov NCT03007745 ↗
Enrolled (actual)
435
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10) — 1.96; 1.73 score on a scale — p=<0.0001
Summary
Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and recognized as a major public health concern, most Veterans with this disorder are undiagnosed and therefore untreated. Access to sleep laboratories for testing is limited particularly for those Veterans living in rural areas and Veterans with disabilities that prevent travel to a sleep center. The goal of this study is to compare a web-based telehealth management strategy to in-person management. The telehealth pathway will enable Veterans to be diagnosed and treated without visiting a sleep center. The investigators believe that telehealth management will increase Veterans' access to this specialized care at a cost that is less than in-person delivery but with similar improvements in daytime function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10) |
1.96; 1.73 | <0.0001 sig |
| SECONDARY Epworth Sleepiness Scale (ESS) |
-3.31; -3.51 | <0.0001 sig |
| SECONDARY Heath Survey Short Form - 12 (SF-12) Physical Component |
0.04; -0.05 | 0.4116 |
| SECONDARY Center for Epidemiological Studies Depression Questionnaire (CES-D) |
-2.76; -2.38 | <0.0003 sig |
| SECONDARY Insomnia Severity Index (ISI) |
-5.94; -5.60 | <0.0001 sig |
| SECONDARY Health Utilities Index (HUI) |
0.7036; 0.7165 | — |
| SECONDARY EuroQol (EQ-5D) VAS |
68.82; 67.32 | — |
| SECONDARY Worker Alliance Inventory - Short Revised (WAI-SR) |
56.38; 64.68 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ-8) |
19.44; 19.84 | >0.05 |
| SECONDARY Adherence to Autoadjusting CPAP Treatment |
3.29; 2.91 | 0.308 |
Eligibility Criteria
Inclusion Criteria
Veterans must meet the following inclusion criteria prior to enrollment:
- Referral to one of the participating sleep centers for evaluation of suspected OSA
- Access in the home to the internet, e-mail, and phone on all days
- Fluent in English as assessed on the initial phone contact
Exclusion Criteria
Veterans will be excluded from the study for the following reasons:
- Unable or unwilling to provide informed consent and complete required questionnaires
- Previous diagnosis of:
- obstructive sleep apnea (OSA)
- central sleep apnea (50% of apneas on diagnostic testing are central apneas)
- Cheyne-Stokes breathing
- obesity hypoventilation syndrome
- narcolepsy
- Previous treatment with positive airway pressure, non-nasal surgery for OSA, or current use of supplemental oxygen
- A clinically unstable medical condition in the previous 2 months as defined by a new diagnosis, e.g.:
- pneumonia
- myocardial infarction
- congestive heart failure
- unstable angina
- thyroid disease
- depression or psychosis
- ventricular arrhythmias
- cirrhosis
- surgery
- recently diagnosed cancer
- Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 3 months
- Women who are pregnant or women who are sexually active and of child-bearing age who are not using some form of contraceptive
- Unable to perform tests due to inability to communicate verbally, inability to read and write, and visual, hearing or cognitive impairment
Data sourced from ClinicalTrials.gov (NCT03007745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.