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Use of the Z-cushion in patients with positional Obstructive Sleep Apnea Syndrome: A randomized controlled trial

Use of the Z-cushion in patients with positional Obstructive Sleep Apnea Syndrome: A randomized controlled trial - Z-cushion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36124
Enrollment
44
Registered
2011-07-05
Start date
2011-08-24
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Disturbed breathing Obstructive Sleep Apnea

Interventions

Subjects will sleep every night with the Z-cushion during a 1 month period.

Sponsors

Gelre Ziekenhuizen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years or older Ability to understand and read Dutch Diagnosis of symptomatic mild or moderate OSAS (5

Exclusion criteria

Exclusion criteria: Central sleep apnea syndrome / Cheyne-Stokes respiration Signs of severe nasal obstruction Major facial or pharyngeal anatomic abnormalities likely to require surgery Night or rotating shift work Severe chronic heart failure Known history of a known cause of daytime sleepiness and severe sleep disruption (e.g. insomnia, PLMS, narcolepsy)

Design outcomes

Primary

MeasureTime frame
Assessing the efficacy in AHI reduction using the Z-cushion compared to delay of treatment in patients with mild and moderate positional OSAS. AHI will be assessed by PSG.

Secondary

MeasureTime frame
Assessing the efficacy with regard to • sleepiness • reducing the sleep time in supine posture • reducing the number of O2 saturation dips using the Z-cushion compared to delay of treatment in patients with mild and moderate positional OSAS. Sleepiness will be assessed by the Epworth Sleepiness Scale. (M. W. Johns, 1991; 1994) Sleep time in supine posture and O2 saturation dips will be assessed by PSG.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)