Inspiratory airflow limitation during sleep: its relationship to functional complaints

ISRCTN ISRCTN95777169
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

Department of Psychiatry & Behavioral Science
Putnam Hall
Stony Brook University
Stony Brook
New York
11794-8790
United States of America

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesPatients 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) studiedUpper airway resistance syndrome
InterventionFollowing 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 typeOther
Primary outcome measure1. Fatigue
2. Daytime sleepiness
3. Sleep quality
Secondary outcome measures1. Pain
2. Headache
3. Gastrointestinal discomfort
4. Metabolic risk factors
5. Hyperarousal
Overall study start date11/09/2006
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteria1. 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 criteria1. 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 enrolment11/09/2006
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • United States of America

Study participating centre

Department of Psychiatry & Behavioral Science
New York
11794-8790
United States of America

Sponsor information

Respironics, Inc (USA)
Industry

1001 Murry Ridge Lane
Murrysville
Pennsylvania
15668-8550
United States of America

Website http://www.respironics.com
ROR logo "ROR" https://ror.org/03kw6wr76

Funders

Funder type

Industry

Respironics, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan