Condition category
Respiratory
Date applied
08/09/2006
Date assigned
25/09/2006
Last edited
25/09/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joan Broderick

ORCID ID

Contact details

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

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

http://www.respironics.com

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

Publication citations

Additional files

Editorial Notes