Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Stony Brook Research Foundation #1051610
Study information
Scientific title
Acronym
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.
Ethics approval
Stony Brook University Internal Review Board (reference number: 2006-6309), approved on the 28th August 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
11/09/2006
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
11/09/2006
Recruitment end date
30/06/2008
Locations
Countries of recruitment
United States of America
Trial participating centre
Department of Psychiatry & Behavioral Science
New York
11794-8790
United States of America
Sponsor information
Organisation
Respironics, Inc (USA)
Sponsor details
1001 Murry Ridge Lane
Murrysville
Pennsylvania
15668-8550
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Respironics, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary