Contact information
Type
Scientific
Contact name
Dr Robert Boyle
ORCID ID
Contact details
Clinical Senior Lecturer in Paediatric Allergy
Imperial College London - St. Mary's Campus
Department of Paediatrics
Wright Fleming Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3990
r.boyle@nhs.net
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
11/MRE00/6
Study information
Scientific title
A single-blind placebo-controlled trial to determine the effect of the airsonett airshower on sleep quality
Acronym
Study hypothesis
1. In adults with allergic rhinitis sensitised to dust mite, cat or dog and with significant rhinitis-related sleep disturbance (NRQLQ=3), treatment with nocturnal temperature-controlled laminar airflow (TLA) results in improved total symptom score compared to placebo device, on the second night of treatment.
2. In adults with allergic rhinitis sensitised to dust mite, cat or dog and with significant rhinitis-related sleep disturbance (NRQLQ=3), nocturnal TLA results in reduced nasal IL-5, reduced diurnal variation in peak nasal inspiratory flow, reduced nasal nitric oxide (NO), reduced modified NRQLQ score (i.e. scored over past 48 hours rather than 1 week), improved sleep parameters as measured by polysomnography and the Somnomat.
Ethics approval(s)
Scotland A Research Ethics Committee, 28/02/2011, ref: 11/MRE00/6
Study design
Single-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Allergic rhinitis
Intervention
1. Four nights of study two with placebo Protexo device and two with active Protexo device
2. Allerguard pillow protectors to be used on all four nights
Intervention type
Other
Primary outcome measure
Total nasal symptom score (itching, sneezing, rhinorrhoea, congestion rated as none=0, mild=1, moderate=2, severe=3)
Secondary outcome measures
1. Arousal index as measured by polysomnography
2. Other polysomnography parameters
3. Spirometry
4. Exhaled NO, nasal NO as measured by NIOX MINO device
5. Peak nasal inspiratory flow
6. Nasal inflammometry nasal secretions collected bilaterally using filter paper strips (7x30 mm)
7. Somnomat
8. Visual analogue scale for sleepiness 100 mm scale from extremely sleepy (0 mm) to not sleepy at all (100 mm)
9. Visual analogue scale for sleep quality 100 mm scale from worst nights sleep ever (0 mm) to best nights sleep ever (100 mm)
Overall study start date
24/03/2011
Overall study end date
26/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-65
2. Doctor-diagnosed allergic rhinitis
3. Sensitised to house dust mite, cat or dog
4. Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire more than or equal to 3
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
Both
Target number of participants
10
Participant exclusion criteria
1. Current smoker
2. Moderate/severe asthma
3. Current medication which cannot be stopped and may affect allergic inflammation or sleep
4. Body mass index (BMI) > 30
5. Known sickle cell disease
6. Adenotonsillar hypertrophy
7. Current immunotherapy
Recruitment start date
24/03/2011
Recruitment end date
26/05/2011
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Imperial College London
London
W2 1PG
United Kingdom
Sponsor information
Organisation
Airsonett AB (Sweden)
Sponsor details
Metallgatan 33
Ängelholm
SE 262 72
Sweden
+46 (0)4 314 025 30
info@airsonett.com
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
Imperial College London (UK)
Alternative name(s)
Imperial College of Science, Technology and Medicine, Imperial College London in United Kingdom, imperialcollege, Imperial College London, UK, Imperial College London, London, England, ICL
Funding Body Type
government organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|