To assess the efficacy of reducing the sleep time in supine posture with positional therapy using the Z-cushion compared to compared to delay of treatment in patients with mild and moderate positional OSAS.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Obstructive Sleep Apnea Syndrome (OSAS) is an affliction, characterised by
repeated episodes of complete or partial collapse of the upper airways. The
nocturnal episodes interfere with normal, restful sleep and are responsible for
symptoms such as extreme tiredness, poor concentration, and fatigue. OSAS is
also associated with an increased risk of cardiovascular and cerebrovascular
morbidity and mortality. The diagnosis of OSAS is based on the presence of
symptoms (e.g. snoring, sleepiness, fatigue and inattention) and the
apnea-hypopnea index (AHI). The syndrome can be divided in positional and
non-positional OSAS. Positional dependent OSAS patients show an increase in
sleep-related breathing abnormalities when lying in the supine sleeping
position compared to the lateral sleeping position. Positional therapy is
recently gaining interest of pulmonologists for the treatment of mild OSAS
where 49.5 percent of the patients are position dependent. Positional therapy
seems to be equivalent to the use of CPAP in the ability to normalize the AHI
in this group of patient with mild OSAS. The positional therapy consists of the
patient stitching a pocket with a tennis ball inside onto the back of his
pyjama, also called the tennis ball technique (TBT). However this positional
therapy has a low patient compliance, because many patients experience this
treatment as too uncomfortable to carry on with. This study tries to answer the
call for the search of a comfortable and ergonomic positional therapy, which
increases compliance for this therapy in positional OSAS patients.
Study objective
To assess the efficacy of reducing the sleep time in supine posture with
positional therapy using the Z-cushion compared to compared to delay of
treatment in patients with mild and moderate positional OSAS.
Study design
This study will be conducted according to an open randomized controlled trial
design at Gelre Hospital in Zutphen.
Intervention
Subjects will sleep every night with the Z-cushion during a 1 month period.
Study burden and risks
There is no risk associated with the study. The benefit will be in reducing
sleepiness. OSAS treatment can only be done in OSAS patients. The burden is
limited to one extra polysomnograpy in a sleep centre.
Den Elterweg 77
7207 AE Zutphen
NL
Den Elterweg 77
7207 AE Zutphen
NL
Listed location countries
Age
Inclusion criteria
18 years or older
Ability to understand and read Dutch
Diagnosis of symptomatic mild or moderate OSAS (5 < AHI < 30)
Diagnosis positional OSAS (2*AHInonsupine <= AHIsupine)
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35682.044.11 |