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Inspiratory airflow limitation during sleep: its relationship to functional complaints

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95777169
Enrollment
20
Registered
2006-09-25
Start date
2006-09-11
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper airway resistance syndrome Respiratory Upper airway resistance syndrome

Interventions

Following baseline assessment, participants will be randomised to the experimental condition: therapeutic CPAP (n=10) or sham CPAP (n=10). A permuted blocking procedure will be used for the randomisat

Sponsors

Respironics, Inc (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Fatigue 2. Daytime sleepiness 3. Sleep quality

Secondary

MeasureTime frame
1. Pain 2. Headache 3. Gastrointestinal discomfort 4. Metabolic risk factors 5. Hyperarousal

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026