Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-22 @ 6:12 AM
Study NCT ID:
NCT02553902
Status:
UNKNOWN
Last Update Posted:
2018-04-11
First Post:
2015-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
Sponsor:
Onze Lieve Vrouwe Gasthuis
Organization:
Study Overview
Official Title:
Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
OBJECTIVES:
To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).
HYPOTHESIS:
The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.
STUDY DESIGN:
A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.
STUDY POPULATION:
Patients diagnosed with moderate POSA according to polysomnography (PSG) results.
INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:
The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.
OUTCOME MEASURES:
AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)
SAMPLE SIZE / DATA ANALYSIS:
100 subjects in each treatment group, total of 200 patients.
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:
The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.
To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).
HYPOTHESIS:
The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.
STUDY DESIGN:
A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.
STUDY POPULATION:
Patients diagnosed with moderate POSA according to polysomnography (PSG) results.
INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:
The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.
OUTCOME MEASURES:
AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)
SAMPLE SIZE / DATA ANALYSIS:
100 subjects in each treatment group, total of 200 patients.
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:
The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: