|- candidate number||9065|
|- NTR Number||NTR2732|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-feb-2011|
|- Secondary IDs||NL34934.044.10 / P10-47; CCMO / MEC Medisch Spectrum Twente|
|- Public Title||POST study.|
|- Scientific Title||Positional therapy in patients with positional Obstructive Sleep Apnea Syndrome: A randomized controlled trial.|
|- hypothesis||Primary hypothesis: Position therapy reduces sleep time in supine posture using the Sleep Position Trainer (SPT) in equal amount as the position band (PB) in patients with mild and moderate positional OSAS.
Secondary hypothesis: The Sleep Position Trainer (SPT) increases patient's compliance compared to the position band (PB).
|- Healt Condition(s) or Problem(s) studied||Obstructive sleep apnea syndrome|
|- Inclusion criteria||1. 18 years or older;|
2. Ability to understand, read and write Dutch;
3. Ability to follow up;
4. Diagnosis of symptomatic mild or moderate OSAS (5 < AHI < 30);
5. Diagnosis positional OSAS (2*AHInonsupine ≤ AHIsupine);
6. AHInonsupine < 5.
|- 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);
7. Seizure disorder;
8. Known medical history of mental retardation, memory disorders or psychiatric disorders;
9. The inability to provide informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||14-feb-2011|
|- planned closingdate||1-aug-2011|
|- Target number of participants||60|
|- Interventions||Subjects will sleep every night with the position training device during a 1 month period. The small device is placed in an elastic band stretched around the subject's lower chest. During sleep the device registers the sleep position of the subject and it will vibrate when the subject lays in supine posture. |
The positional therapy that is used as control consists of the subject getting a sleep position band. Whenever a patient rolls into supine posture during sleep, he feels the pressure of the obstruction and is likely to change his posture.
|- Primary outcome||Sleeping time in supine posture as percentage of total sleep time (%STS) and compliance.|
|- Secondary outcome||1. Mean SaO2;|
2. Lowest SaO2;
3. Apneu Hypopneu Index (AHI);
4. Apneu Hypopneu Index in supine posture (AHIs);
5. Apneu Hypopneu Index in nonsupine posture (AHIns);
6. Total Sleep Time;
7. Total Sleep Time with SaO2 < 90%;
8. Symptom reduction;
9. Therapy preference.
|- Timepoints||Subjects will sleep with the device during a 1 month period. Measurements will take place before and right after the intervention.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD. M.M.M. Eijsvogel|
|- CONTACT for SCIENTIFIC QUERIES||MSc. M.G.J. Keizer|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente|
|- Brief summary||Rationale: |
This study tries to answer the call for the search of a comfortable and ergonomic positional therapy, which increases compliance for positional therapy in posture dependent OSAS patients.
To assess equivalence in reducing sleep time in supine posture between positional therapy using the position training device and the sleep position band in patients with mild and moderate positional OSAS.
This study will be conducted according to an open randomized controlled trial design at Medisch Spectrum Twente, Enschede.
The subjects for the study will be recruited from the department of pulmonary medicine at Medisch Spectrum Twente in Enschede and Oldenzaal, the Netherlands. Subjects will be males and females with diagnosis of symptomatic mild or moderate OSAS (5 < AHI < 30) and the diagnosis positional OSAS (2*AHInonsupine ≤ AHIsupine & AHInonsupine < 5).
Subjects will sleep every night with the position training device during a 1 month period. The small device is placed in an elastic band stretched around the subject's lower chest. During sleep the device registers the sleep position of the subject and it will vibrate when the subject lays in supine posture. The positional therapy that is used as control consists of the subject getting a sleep position band. Whenever a patient rolls into supine posture during sleep, he feels the pressure of the ball and is likely to change his posture.
|- Main changes (audit trail)|
|- RECORD||3-feb-2011 - 15-feb-2011|