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 design	Randomised controlled trial
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
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

Sponsor information

Respironics, Inc (USA)
Industry

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

Website	http://www.respironics.com
"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 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