Clinical trial NCT02088723: Testing the Elevation as Sleep Apnea Treatment
Official title: The Influence of Elevation of the Head of the Bed in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep
Keywords: Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Polysomnography
Sleep
Patient Positioning
Lead sponsor: Pulmonar
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Apnea-Hypopnea Index compared by the polysomnography standard versus polysomnography with the elevation of the head of the bed
timeFrame: The difference between the first exam to the second will be 2 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Criciúma
country: Brazil
facility: PULMONAR
state: Santa Catarina
Study officials:
affiliation: Pulmonar
name: Fábio José FB Souza, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: