Use of the Z-cushion in patients with positional Obstructive Sleep Apnea Syndrome.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25515

Enrollment

Registered

2011-03-28

Start date

2011-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Obstructive Sleep Apnea Syndrome Obstructief Slaap Apneu Syndroom

Interventions

Subjects who participate in this study will sleep one month with either the Z-cushion (NEG 0608) or will receive no treatment for the first month.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years or older; 2. Ability to understand and read Dutch; 3. Diagnosis of symptomatic mild or moderate OSAS (5 < AHI < 30); 4. Diagnosis positional OSAS (2*AHInonsupine ≤ AHIsupine).

Exclusion criteria

Exclusion criteria: 1. Central sleep apnea syndrome / Cheyne-Stokes respiration; 2. Signs of severe nasal obstruction; 3. Major facial or pharyngeal anatomic abnormalities likely to require surgery; 4. Night or rotating shift work; 5. Severe chronic heart failure; 6. Known history of a known cause of daytime sleepiness and severe sleep disruption (e.g. insomnia, PLMS, narcolepsy).

Design outcomes

Primary

Measure	Time frame
Assessing the efficacy in Apnea-Hypopnea Index (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

Measure	Time frame
Assessing the efficacy with regard to: 1. Sleepiness; 2. Reducing the sleep time in supine posture; 3. 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.	—

Measure

Time frame

Assessing the efficacy with regard to: 1. Sleepiness; 2. Reducing the sleep time in supine posture; 3. 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.

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Contacts

Public ContactE. Lammers

Gelre ziekenhuizen Department of Pulmonary Medicine Den Elterweg 77

e.lammers@gelre.nl+31 (0)57 5592924

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)