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

A single-blind placebo-controlled trial to determine the effect of the airsonett airshower on sleep quality

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67027605

Enrollment

Registered

2011-03-25

Start date

2011-03-24

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis Respiratory Allergic rhinitis, unspecified

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Total nasal symptom score (itching, sneezing, rhinorrhoea, congestion rated as none=0, mild=1, moderate=2, severe=3)	—

Secondary

Measure	Time frame
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 night?s sleep ever (0 mm) to best night?s sleep ever (100 mm)	—

Measure

Time frame

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 night?s sleep ever (0 mm) to best night?s sleep ever (100 mm)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026