Testing the Elevation as Sleep Apnea Treatment (TEST)

The Influence of Elevation of the Head of the Bed in Patients With Obstructive Sleep Apnea

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep
• Intervention / Treatment: Behavioral: Head of bed elevation

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).

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Criciúma, Santa Catarina, Brazil, 88811-503
      • PULMONAR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: head of bed elevation; Compare the apnea hypopnea index with the patient in standard polysomnography and in elevated polysomnography (head of bed elevation)	Behavioral: Head of bed elevation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The difference between the first exam to the second will be 2 weeks.

Collaborators and Investigators

• Sponsor: Pulmonar
• Investigators: Principal Investigator: Fábio José FB Souza, MD MSc, PULMONAR

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Sleep; Polysomnography; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Patient Positioning
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Apnea-PULMONAR-1