Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02045576
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2013-11-26
Brief Title:
RCT Oral Appliance Therapy and Sleep Position Trainer in Patients With Position Dependant Obstructive Sleep Apnea
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Positional Therapy With the Sleep Position Trainer Versus Oral Appliance Therapy in Patients With Position Dependent Obstructive Sleep Apnea A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSA
Brief Summary:
SUMMARY Rationale Fifty-six percent of patients with Obstructive Sleep Apnea OSA are position dependent defined as having an AHI which is at least twice as high in supine sleeping position compared to the AHI during sleep in other positions Standard therapy for patients having mild or moderate POSA is treatment with an Oral Appliance Trainer OAT Recently a new device Sleep Position Trainer SPT is been introduced especially for patients with POSA
Objective To compare the effect of positional therapy with the SPT versus OAT on polysomnographic PSG parameters to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for positional therapy over a long term
Study design Randomised controlled trial Study population The participants of the research will be recruited from the departments of Otolaryngology and Clinical Neurophysiology Saint Lucas Andreas Hospital Amsterdam the Netherlands
Participants will be males or females older than 18 years with diagnosis of positional OSA
Intervention The SPT is a sensor positioned in an elastic band attached around the body The SPT measures the body position and vibrates when the patient lies in supine position Oral appliance therapy OAT is an intra-oral prosthesis which holds the mandible in a protrusive position Because of this position more pharyngeal space will be available and the AHI will decrease After randomisation the first group n45 will sleep for a period of 90 - 2 days with the SPT every night The second group n45 will also sleep for a period of 90 - 2 days only with OAT After this period the PSG is repeated Long- term outcome in AHI is measured by repeating the PSG after 1 year Main study parameters endpoints Primary endpoints reduction of PSG parameters in particular AHI AI HI DI reduction of of sleeping supine sleep position without disturbance of the sleep quality
Secondary endpoints Outcome of Quality of Life questionnaires EQ-5D ESS FOSQ and MFIQ
Compliance and learning effect will also be evaluated for the time period of 3 and 12 months Finally cardiovascular parameters like blood pressure pulse rate and BMIneck circumference will be assessed
Nature and extent of the burden and risks associated with participation benefit and group relatedness The risks for patients participating in this study are negligible Inconveniences of the SPT can be discomfort caused by irritation of the band difficulties with an increased sleeping period on the side or difficulties sleeping with the SPT This can be compensated by the expected improvement of sleep quality caused by the therapy Possible side effects of OAT may be discomfort in the jaw sensitivity of the teeth and a dry mouth Withdrawing from this therapy means immediate relief of inconveniences
Objective To compare the effect of positional therapy with the SPT versus OAT on polysomnographic PSG parameters to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for positional therapy over a long term
Study design Randomised controlled trial Study population The participants of the research will be recruited from the departments of Otolaryngology and Clinical Neurophysiology Saint Lucas Andreas Hospital Amsterdam the Netherlands
Participants will be males or females older than 18 years with diagnosis of positional OSA
Intervention The SPT is a sensor positioned in an elastic band attached around the body The SPT measures the body position and vibrates when the patient lies in supine position Oral appliance therapy OAT is an intra-oral prosthesis which holds the mandible in a protrusive position Because of this position more pharyngeal space will be available and the AHI will decrease After randomisation the first group n45 will sleep for a period of 90 - 2 days with the SPT every night The second group n45 will also sleep for a period of 90 - 2 days only with OAT After this period the PSG is repeated Long- term outcome in AHI is measured by repeating the PSG after 1 year Main study parameters endpoints Primary endpoints reduction of PSG parameters in particular AHI AI HI DI reduction of of sleeping supine sleep position without disturbance of the sleep quality
Secondary endpoints Outcome of Quality of Life questionnaires EQ-5D ESS FOSQ and MFIQ
Compliance and learning effect will also be evaluated for the time period of 3 and 12 months Finally cardiovascular parameters like blood pressure pulse rate and BMIneck circumference will be assessed
Nature and extent of the burden and risks associated with participation benefit and group relatedness The risks for patients participating in this study are negligible Inconveniences of the SPT can be discomfort caused by irritation of the band difficulties with an increased sleeping period on the side or difficulties sleeping with the SPT This can be compensated by the expected improvement of sleep quality caused by the therapy Possible side effects of OAT may be discomfort in the jaw sensitivity of the teeth and a dry mouth Withdrawing from this therapy means immediate relief of inconveniences
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None