Effects of circadian disruption and sleep deprivation in respiratory disorders

Withdrawn

• Conditions: Obstructive sleep apnea; Asthma; Respiratory - Sleep apnoea; Respiratory - Asthma

• Registration Number: ACTRN12605000087651
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

OSA: Untreated subjects with moderate to severe OSA (RDI > 30).
Asthma: Asthmatic subjects (ATS Criteria) will be recruited from asthma clinics associated with AIs. We will use clinic patients (current non-smokers and minimal smoking history)with moderate to severe asthma based on NAC guidelines i.e. those requiring short acting beta agonists 3 or more days week or with nocturnal symptoms more than once per fortnight.
Controls: We will recruit healthy controls.

Exclusion Criteria

OSA: use of alcohol> 40gm/day, psychotropic medication, intercurrent asthma, other unstable medical conditions or evidence of clinically significant awake respiratory failure.
Asthma:We will exclude subjects on long-acting bronchodilators (salmeterol, formoterol, tiotropium and theophylline). Inhaled corticosteroids will be held constant from screening into studies and use of short acting beta agonists will be permitted and monitored during protocols.
Controls: similar exclusion criteria as for the OSA and asthma subjects
Subjects with the presence of asthma (ATS criteria) and OSA will be excluded. The absence of OSA will be determined using a validated nocturnal respiratory monitor over 2 nights (Autoset T, ResMed).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total number of lapses (defined as RT> 500ms) during a 10-min psychomotor vigilance task (PVT)[];Mean slowest 10% metric of the PVT during a 10-min psychomotor vigilance task (PVT)[];Subjective sleepiness as determined by the KSS[];Changes in Rsr and expired NO, and changes in RDI and sleep architecture during the period of sleep restriction, compared to baseline values in patients and to effects in healthy control subjects during the sleep restriction period.[]

Secondary Outcome Measures

Name	Time	Method
Other measures of neurocognitive functioning, including working memory function, cognitive throughput, arithmetic and time estimation.[];Other measures of subjective alertness and functioning capabilities.[];Core body temperature for circadian phase assessments.[];Objective levels of alertness measuring using the waking EEG.[]