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Surfactant for Obstructive Sleep Apnea in Patients with Primary Sjogren’s Syndrome: A randomised, placebo controlled study.

Surfactant for OSA in Patients with Primary Sjogren’s Syndrome for improvement of AHI and Sicca Symptoms: A randomised, placebo controlled study.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000113853
Enrollment
14
Registered
2012-01-24
Start date
2011-04-18
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Our group has recently found that women with primary Sjogren’s syndrome (an autoimmune disease causing dry eyes and mouth) are considerably more likely to suffer obstructive sleep apnoea (OSA) compared to women without Sjogren’s syndrome. OSA is a common condition in which the upper airway repeatedly closes during sleep and can lead to severe daytime sleepiness, one of the common problems reported by Sjogren’s sufferers. A likely key cause of OSA in Sjogren’s syndrome is reduced and stickier airway secretions that may predispose to airway obstruction and disturbed sleep at night. Recent research in OSA patients without Sjogren’s syndrome has shown that lubricating the upper airway with a substance called surfactant improves OSA. Surfactants are naturally produced in the lung and work by decreasing the “stickiness” (surface tension) of fluids. Therefore, at least in OSA patients without Sjogren’s syndrome, surfactants applied to the upper airway appear to help the airway to stay open and reopen more easily if it becomes closed. Women with Sjogren’s syndrome are likely to similarly benefit from this form of treatment. The aim of this study is to determine whether the topical application of surfactant in women with primary Sjogren’s Syndrome who have obstructive sleep apnoea as well, will reduce the severity of their OSA and salivary stickiness and will improve their symptoms of overnight dryness and general morning well-being or not.

Interventions

Surfactant (abbott's Survanta) 4.0mls topically into upper airways(half the dose via oropharynx and half via nasopharynx). The dose was given at baseline prior to sleep onset and repeated 3.5 hours after sleep onset. On the consecutive night surfactant will be crossed over by 4.0 mls of 0.9 % normal saline via same route and with same frequency.

Sponsors

Adelaide Institute for Sleep Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Obstructive Sleep Apnea Primary Sjogren's Syndrome

Exclusion criteria

Severe gag reflex Severe cognitive impairment Not willing to participate

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026