A randomised controlled trial of a simplified management strategy in OSA

A randomised cphase 3 study to evaluate the efficacy of a simplified diagnostic and management system in management of obstructive sleep apnoea (OSA), comparing outcomes (improvement in daytime sleepiness) against best current practice

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000064606

Enrollment

240

Registered

2005-08-01

Start date

2004-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The intervention group is group of patients with moderate-severe OSA, to whom a simplified diagnostic (home and oximetry) and management system (Specialist nurse led application of home, autoset continuous positive airway pressure) was applied.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

ESS 8+2 or more symtoms of OSA

Exclusion criteria

CSRCVA in last 12 monthsactive psychiatric disease

Outcome results