Positional therapy for obstructive sleep apnea: an objective measurement of efficacy and patients’ usage at home.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000056998

Acronym

Enrollment

Registered

2011-01-17

Start date

2009-07-15

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

Brief summary

Positional therapy that prevents patients from sleeping supine has been used for many years to manage positional obstructive sleep apnea (OSA). However, the actual usage and long term efficacy of this therapy have never been objectively assessed.The aims of this study are to: 1) measure objective nightly usage of this positional device at home and, 2) assess its efficacy after 3 months of treatment at home.

Interventions

Patients with positional sleep apnea are equipped with the positional device preventing sleep in supine position. Patients are instructed to use the device every night during a 3 months period. An actigraphic device, (movement sensor recorder system, Actiwatch, CamNtech Ltd, Cambridge, UK), is inserted inside the positional device in order to assess compliance; i.e., detect when patients used it.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

Positional sleep apnoea Intolerance to other treatments such as CPAP or mandibular advancement device

Exclusion criteria

Intolerance to the positional device during the test night

Outcome results