Inspiratory airflow limitation during sleep: its relationship to functional complaints
ISRCTN | ISRCTN95777169 |
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DOI | https://doi.org/10.1186/ISRCTN95777169 |
Secondary identifying numbers | Stony Brook Research Foundation #1051610 |
- Submission date
- 08/09/2006
- Registration date
- 25/09/2006
- Last edited
- 25/09/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joan Broderick
Scientific
Scientific
Department of Psychiatry & Behavioral Science
Putnam Hall
Stony Brook University
Stony Brook
New York
11794-8790
United States of America
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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. |
Ethics approval(s) | Stony Brook University Internal Review Board (reference number: 2006-6309), approved on the 28th August 2006. |
Health condition(s) or problem(s) studied | Upper airway resistance syndrome |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | 1. Fatigue 2. Daytime sleepiness 3. Sleep quality |
Secondary outcome measures | 1. Pain 2. Headache 3. Gastrointestinal discomfort 4. Metabolic risk factors 5. Hyperarousal |
Overall study start date | 11/09/2006 |
Completion date | 30/06/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 20 |
Key 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 |
Key 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 |
Date of first enrolment | 11/09/2006 |
Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Department of Psychiatry & Behavioral Science
New York
11794-8790
United States of America
11794-8790
United States of America
Sponsor information
Respironics, Inc (USA)
Industry
Industry
1001 Murry Ridge Lane
Murrysville
Pennsylvania
15668-8550
United States of America
Website | http://www.respironics.com |
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https://ror.org/03kw6wr76 |
Funders
Funder type
Industry
Respironics, Inc. (USA)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |