Phase 3 N=169 Randomized Single-blind

Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT01108081 ↗

Enrolled (actual)

169

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Change Over 6 Months in Epworth Sleepiness Scale Score — -0.23; -1.05; 0.43; -2.62 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Physical activity (Behavioral); Diet (Behavioral); Health education (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change Over 6 Months in Epworth Sleepiness Scale Score	-0.23; -1.05; 0.43; -2.62	—
SECONDARY Change Over 6 Months in Quality of Life	0.24; 0.15; -0.33; 1.24	—

Summary

This project is investigating whether both moderate-intensity physical activity and dietary weight loss will independently reduce sleep apnea symptoms and improve quality of life.

Eligibility Criteria

Inclusion Criteria

Physician diagnosis of sleep apnea
Apnea-hypopnea index >10/hr
BMI over 24 kg/m2

Exclusion Criteria

Angina pectoris
History of myocardial infarction within 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01108081). 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.