Inspiratory airflow limitation during sleep: its relationship to functional complaints

Completed

• Conditions: pper airway resistance syndrome; Respiratory; Upper airway resistance syndrome

• Registration Number: ISRCTN95777169
• Lead Sponsor: Respironics, Inc (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Physician-confirmed diagnosis of UARS
2. Aged between 21 years or over and 65 years or under
3. Able to speak and read English
4. Ability to tolerate only one caffeinated beverage in the morning

Exclusion Criteria

1. Currently taking an opiate, benzodiazepine, sedative, hypnotic, stimulant, or sleeping medication
2. Currently being treated with a lipid lowering or Blood Pressure (BP) medication
3. Diagnosis and/or treatment for sleep apnea, narcolepsy, or periodic limb movement disorder
4. Diagnosis of diabetes, coronary artery disease, Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), stroke, or seizures
5. Body Mass Index (BMI) over 32 (no lower limit)
6. Evidence of overt alcohol or other substance abuse
7. History of allergy to lidocaine or similar local anesthestics
8. Presence of an extreme gag reflex
9. Difficulty breathing through nose
10. Smoking
11. Waking after 10:00 a.m. and going to bed after 12:00 a.m

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Fatigue<br>2. Daytime sleepiness<br>3. Sleep quality

Secondary Outcome Measures

Name	Time	Method
1. Pain<br>2. Headache<br>3. Gastrointestinal discomfort<br>4. Metabolic risk factors<br>5. Hyperarousal