|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Inspiratory airflow limitation during sleep: its relationship to functional complaints |
| ISRCTN | ISRCTN95777169 |
| ClinicalTrials.gov identifier | |
| Public title | Inspiratory airflow limitation during sleep: its relationship to functional complaints |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | Stony Brook Research Foundation #1051610 |
| Study hypothesis | Patients with Upper Airway Resistance Syndrome (UARS) who are randomised to therapeutic Continuous Positive Airway Pressure (CPAP) will demonstrate reduced pain, fatigue, daytime sleepiness, headache, gastrointestinal discomfort, hyperarousal, and metabolic risk factors after three weeks of treatment compared to UARS patients randomised to sham CPAP. |
| Lay summary | |
| Ethics approval | Stony Brook University Internal Review Board (reference number: 2006-6309), approved on the 28th August 2006. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United States of America |
| Disease/condition/study domain | Upper airway resistance syndrome |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 11/09/2006 |
| Anticipated end date | 30/06/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 20 |
| 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 randomisation assignments using two block sizes (four and six). “Allocation concealment” from research assistants conducting outcome assessments will be done to minimise assignment bias and to attempt to maintain blinding of assessors. The study coordinator, who will not have direct contact with participants, will be responsible for implementing randomisation.
Per instruction from the study coordinator, one member of the research team will prepare the CPAP device as therapeutic or sham and provide it to another member of the team (blinded) who will interface with the patients to train them in use of the CPAP and answer questions or coach compliance during the trial. Patients will receive treatment for three weeks and then return for post-treatment assessment. The research assistant responsible for gathering pre- and post-treatment data will also be blinded to experimental condition. |
| Primary outcome measure(s) |
1. Fatigue
2. Daytime sleepiness 3. Sleep quality |
| Secondary outcome measure(s) |
1. Pain
2. Headache 3. Gastrointestinal discomfort 4. Metabolic risk factors 5. Hyperarousal |
| Sources of funding | Respironics, Inc. (USA) |
| Trial website | |
| Publications | |
| Contact name | Dr Joan Broderick |
| Address |
Department of Psychiatry & Behavioral Science
Putnam Hall Stony Brook University Stony Brook |
| City/town | New York |
| Zip/Postcode | 11794-8790 |
| Country | United States of America |
| Sponsor | Respironics, Inc (USA) |
| Address |
1001 Murry Ridge Lane
Murrysville |
| City/town | Pennsylvania |
| Zip/Postcode | 15668-8550 |
| Country | United States of America |
| Sponsor website: | http://www.respironics.com |
| Date applied | 08/09/2006 |
| Last edited | 25/09/2006 |
| Date ISRCTN assigned | 25/09/2006 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|