Testing the Elevation as Sleep Apnea Treatment (TEST)
Primary Purpose
Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Head of bed elevation
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Polysomnography, Sleep, Patient Positioning
Eligibility Criteria
Inclusion Criteria:
- Berlin questionnaire high risk
- Epworth score > 9
- Obstructive Sleep Apnea with an index ≥ 5 events/hour on the polysomnography (The American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events: rules,terminology and technical specifications. American Academy of Sleep Medicine, 2012)
Exclusion Criteria:
- younger than 18 years and older than 80 years
- BMI more than 40 Kg/m2
- heart failure
- renal failure
- uncontrolled respiratory disease
- uncontrolled neurological disease
Sites / Locations
- PULMONAR
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
head of bed elevation
Arm Description
Compare the apnea hypopnea index with the patient in standard polysomnography and in elevated polysomnography (head of bed elevation)
Outcomes
Primary Outcome Measures
Apnea-Hypopnea Index compared by the polysomnography standard versus polysomnography with the elevation of the head of the bed
During the polysomnography there are sensors that detect the airflow by cannula pressure and thermistor. WIth those equipment during the all night the patient will be registered and seen if there is absence of flow (apnea) and/or reduction of flow (hypopnea). The apnea and hypopnea index is done by dividing the number of respiratory events by recording time in hours of sleep (events per hour).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02088723
Brief Title
Testing the Elevation as Sleep Apnea Treatment
Acronym
TEST
Official Title
The Influence of Elevation of the Head of the Bed in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmonar
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if the elevation of the head of the bed in patients with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.
Detailed Description
There are many researches that demonstrate that the position of the patient modified the apnea-hypopnea index(IAH). In supine position the IAH will increase comparing with lateral position during th sleep. However few studies were done with the elevation of the head of the bed.
First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.The main outcome will be to analyze the apnea hypopnea index comparing standard polysomnography (sPSG) with elevated polysomnography (ePSG).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep
Keywords
Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Polysomnography, Sleep, Patient Positioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
head of bed elevation
Arm Type
Experimental
Arm Description
Compare the apnea hypopnea index with the patient in standard polysomnography and in elevated polysomnography (head of bed elevation)
Intervention Type
Behavioral
Intervention Name(s)
Head of bed elevation
Intervention Description
head of bed elevation elevation the head of the bed with 15 cm (head of bed elevation) and compare the apnea-hypopnea index with the standard polysomnography
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index compared by the polysomnography standard versus polysomnography with the elevation of the head of the bed
Description
During the polysomnography there are sensors that detect the airflow by cannula pressure and thermistor. WIth those equipment during the all night the patient will be registered and seen if there is absence of flow (apnea) and/or reduction of flow (hypopnea). The apnea and hypopnea index is done by dividing the number of respiratory events by recording time in hours of sleep (events per hour).
Time Frame
The difference between the first exam to the second will be 2 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Berlin questionnaire high risk
Epworth score > 9
Obstructive Sleep Apnea with an index ≥ 5 events/hour on the polysomnography (The American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events: rules,terminology and technical specifications. American Academy of Sleep Medicine, 2012)
Exclusion Criteria:
younger than 18 years and older than 80 years
BMI more than 40 Kg/m2
heart failure
renal failure
uncontrolled respiratory disease
uncontrolled neurological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio José FB Souza, MD MSc
Organizational Affiliation
Pulmonar
Official's Role
Principal Investigator
Facility Information:
Facility Name
PULMONAR
City
Criciúma
State/Province
Santa Catarina
ZIP/Postal Code
88811-503
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Testing the Elevation as Sleep Apnea Treatment
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