None listed
Conditions
Brief summary
Mouth (oral) route breathing during sleep may be a risk factor for obstructive sleep apnoea (OSA) leading to increased disease severity related to a more collapsible upper airway. CPAP (continuous positive airway pressure) is the current gold standard treatment of choice for severe OSA for mild to moderate OSA CPAP is less convincing and often less well tolerated. Hence a range of alternative treatment options have been utilised with varying degres of success. Because of the lack of effective and iniversally acceptable therapies for OSA there remains a need to develop alternative approaches. One such approach maybe to prevent oral route breathing during sleep which maybe an important contributor to worsening uppder airway obstruction in subjects who breathing oronasally during sleep.
Interventions
A chin strap will be applied. Chin straps are commercially available devices used to prevent oral route breathing and mouth leak during CPAP (continuous positive airway pressure) therapy. A chin strap consists of a piece of soft flexible material designed to support mouth closure. An appropriately fitted Seatec (brand name) chin strap will be fitted. Nasal decongestant will also be used as an intervention to prevent oral route breathing. The chin strap will be applied for the duration of the sle
A chin strap will be applied. Chin straps are commercially available devices used to prevent oral route breathing and mouth leak during CPAP (continuous positive airway pressure) therapy. A chin strap consists of a piece of soft flexible material designed to support mouth closure. An appropriately fitted Seatec (brand name) chin strap will be fitted. Nasal decongestant will also be used as an intervention to prevent oral route breathing. The chin strap will be applied for the duration of the sleep study. Nasal decongestant with oxymetazoline will be 2 sprays in each nostril prior to PSG (polysomnography i.e. sleep study) on the chin strap intervention night only. The two sleep studies i.e with chinstrap& decongestant spray and nil interventions will be seperated by no more than 1 week. PSG will be conducted with the same instrumentation on both study nights including calibrated sound recording and breathing route detection with thermistors. Anthropometric data including age, sex, height, weight, BMI, neck circumference will be collected. Questionnaires including sleep history, WSHQ, ESS, VAS for sleep quality, ease of nasal breathing will be conducted. Nasal Resistance with and without decongestant via posterior rhinomanometry prior to each PSG study. Standard Polysomnography using Compumedics Profusion 3 software. Calibrated sound recording for snoring with Rion SL Meters. Route of breathing using semi-calibrated nasal and oral thermistors. Subject perception questionnaires for sleep quality, dryness of mouth and ease of nasal breathing will be conducted at the end of the overnight study i.e morning. Randomisation will occur via reference to a statistical reference table prior to the first study night and after informed consent. Randomisation will mean the subject will be placed in the group that has no intervention on the first study night or the group that will have the chin strap & nasal spray intervention on the first night. The second study night will follow as chin strap & nasal spray if the first night was no intervention. The second study night will follow as no intervention if the first study night had chin strap & nasal spray.
Sponsors
Professor John Wheatley
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult patients (>18 yrs) presenting to the Westmead Sleep Service for investigation of Sleep Disordered Breathing Sleep Disordered Breathing (SDB). 2. Baseline PSG demonstrating a Respiratory Disturbance Index between 10 and 30 events/hr. 3. Baseline Polysomnography (PSG) demonstrating oro-nasal breathing for > 50% total sleep
Exclusion criteria
1. Severe OSA with an RDI > 30 events/hr 2. Previous oro-nasal surgery 3. Prior motor vehicle accident due to sleepiness 4. Inability to breathe nasally-only 5. Significant co-morbid respiratory, neurological or cardiac disease 6. Diagnosis of another major sleep disorder 7. Acute upper respiratory tract infection at baseline 8. Severe nasal congestion caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator 9.Inability to refrain from use of alcohol on the study nights
Outcome results
None listed