A pilot proposal to determine the effect of the airsonett airshower on sleep quality
| ISRCTN | ISRCTN67027605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67027605 |
| Protocol serial number | 11/MRE00/6 |
| Sponsor | Airsonett AB (Sweden) |
| Funder | Imperial College London (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
|---|---|
| r.boyle@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Total nasal symptom score (itching, sneezing, rhinorrhoea, congestion rated as none=0, mild=1, moderate=2, severe=3) |
| Key secondary outcome measure(s) |
1. Arousal index as measured by polysomnography |
| Completion date | 26/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
W2 1PG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/05/2017: No publications found, verifying study status with principal investigator.
