Reducing Sleep Apnoea for the Prevention of Dementia

Not Applicable

Recruiting

• Conditions: Respiratory - Sleep apnoea; Obstructive Sleep apnoea; Mild cognitive impairment; Subjective cognitive impairment; Neurological - Dementias

• Registration Number: ACTRN12621001190897
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-06
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Subjective cognitive decline (new onset cognitive decline within the last 5 years)
2.Able to provide informed written consent
3.Fluent English literacy
4.Adults aged between 50-75 years
5.Mild – Severe OSA based on an average ODI equal to or greater to 10 with 3% oxygen desaturation determined by oximetry over two nights.

Exclusion Criteria

1.Previous or current CPAP or mandibular device or oxygen user or body position device user (within past 3 months)
2.People highly dependent on medical care
3.Previous diagnosis of dementia or MMSE less than 24
4.Previous major head injury or loss of consciousness equal to or greater than 30 minutes
5.Previous or current substance misuse or use of medicinal cannabis
6.Previous or current neurological disorder diagnosis (e.g. Parkinson’s, multiple sclerosis, epilepsy, stroke)
7.Psychiatric or developmental disorders (e.g. Schizophrenia, bipolar disorder, autism)
8.Current major depression diagnosis
9.Major sleep disorders (e.g. narcolepsy, severe restless legs syndrome, severe insomnia disorder unrelated to a sleep-breathing disorder)
10.Shift workers
11.Any other condition that would, in the Investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures.
12.Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.
13.Prohibited medications
Ongoing use of Anti-psychotic medication, mood stabilizers, benzodiazepines, wakefulness promoters and stimulants. Stable dosing (30 days prior to enrolment) of anti-depressants for non-major depressive disorder permitted. Melatonin or Circadin to be ceased before randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability as assessed by proportion of eligible participants who agree to be randomised, measured using audit of study records. Target proportion is 50%.[Before randomization of each participant];The 6-month and 24-month measurements of ODI will be averaged (with equal weight) and compared to baseline on the WatchPAT device. The target average reduction must be >=30%.[6 and 24 months post-randomisation];Tolerability of the outcome assessment is assessed by percentage of participants from whom we have complete data from either the Paired Associate Learning (PAL) test or the Rey Auditory Verbal Learning Test (RAVLT). Target proportion >=60%. [2 years after randomization. ]