Testing the Elevation as Sleep Apnea Treatment

NCT ID: NCT02088723

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-10-31

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).

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

head of bed elevation

Compare the apnea hypopnea index with the patient in standard polysomnography and in elevated polysomnography (head of bed elevation)

Group Type: EXPERIMENTAL

Head of bed elevation

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmonar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fábio José FB Souza, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Pulmonar

Locations

PULMONAR

Criciúma, Santa Catarina, Brazil

Countries

Brazil

Other Identifiers

Apnea-PULMONAR-1

Identifier Type: -

Identifier Source: org_study_id