A pilot study to investigate the effects of nocturnal humidification on sleep apnea and sleep quality, in patients with Primary Sjogren’s Syndrome(pSS)

Randomised placebo controlled cross-over trial of airway humidification, in patients with pSS(Primary Sjogrens Syndrome) and to study its effect on sleep architecture.

Status

Suspended

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000347864

Enrollment

Registered

2012-03-26

Start date

2012-05-29

Completion date

2012-11-20

Last updated

2026-01-05

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

Conditions

None listed

Brief summary

Excessive dryness of mouth and throat, occurs in patients with Sjogrens Syndrome. This could result in sleep disturbance and predispose to obstructive sleep apnea. A previous study has reported that nocturnal humidification (moistening the mouth and throat at night) improved mouth dryness and decreased sleep disturbance. It might be possible therefore to improve sleep apnea and sleep quality in patients with Sjogrens Syndrome by using special mask and device which will deliver humidified air and keep mouth and throat moistened, during night.Our aim is to find out the usefulness of nocturnal humidification (giving humidified air through a mask during sleep at night) in improving sleep apnea and sleep quality in patients with Sjogrens Syndrome.

Interventions

High intensity humidifier machine(AIRVO), which is currently in clinical use, will be used for nocturnal humidification in patients with pSS.The humidifier device gives warmed and humidified air to the participant through a mask.This device will be used overnight, on the study night during sleep.The patient will have a sleep study performed on this night and the subjective quality of sleep will be assessed next day. Following this there will be a washout period of 1 week. After 1 week the cross over trial will be performed.The sleep study and subjective sleep quality will be assessed during the cross-over trial. Overall, this study involves use of the humidifier device for 1 night , by each participant who is involved in the study.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Patients with primary Sjogrens Syndrome (pSS), as per the revised version of the European criteria proposed by the American-European Consensus Group, with an Apnea-hypopnea index (AHI) of >10 events/hour, measured on polysomnogram.

Exclusion criteria

Inability to give consent, co-existing sleep disorders like restless leg syndrome,narcolepsy etc, major medical co-morbidities like unstable heart disease, unstable airways disease,uncontrolled diabetes mellitus, patients on chemotherapy

Outcome results