A pilot proposal to determine the effect of the airsonett airshower on sleep quality

ISRCTN	ISRCTN67027605
DOI	https://doi.org/10.1186/ISRCTN67027605
Secondary identifying numbers	11/MRE00/6

Submission date: 22/03/2011
Registration date: 25/03/2011
Last edited: 12/05/2017

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 Robert Boyle
Scientific

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

Phone	+44 (0)20 7594 3990
Email	r.boyle@nhs.net

Study information

Study design	Single-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	A single-blind placebo-controlled trial to determine the effect of the airsonett airshower on sleep quality
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	26/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	10
Key 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
Key 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
Date of first enrolment	24/03/2011
Date of final enrolment	26/05/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Imperial College London

London
W2 1PG
United Kingdom

Sponsor information

Airsonett AB (Sweden)
Industry

Metallgatan 33
Ängelholm
SE 262 72
Sweden

Phone	+46 (0)4 314 025 30
Email	info@airsonett.com
Website	http://www.airsonett.com/

Funders

Funder type

University/education

Imperial College London (UK)
Government organisation / Universities (academic only)

Alternative name(s): Imperial College of Science, Technology and Medicine, Imperial College London, UK, Imperial College London, London, England, Imperial College London in United Kingdom, imperialcollege, ICL
Location: United Kingdom

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

Editorial Notes

12/05/2017: No publications found, verifying study status with principal investigator.