Obstructive Sleep Apnea study: Home Sleep Apnea Test
Official title ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
ClinicalTrials.gov ID: NCT04335994
What this study is testing
- What it's testing
- The study wants to see if a home sleep apnea test leads to more people finishing sleep testing within six months compared to the standard lab test, and also looks at cost, satisfaction, CPAP use, and changes in thinking, mood, sleep and daily function.
- Who it's for
- Adults who have Alzheimer’s disease, vascular cognitive impairment, mild cognitive impairment, Parkinson’s disease with dementia, Lewy body dementia, mixed dementia, or similar conditions and may have sleep apnea.
- What's involved
- Participants are randomly assigned to either a home sleep apnea test or an overnight lab sleep study; they may receive CPAP treatment if sleep apnea is found, and will have follow‑up visits and questionnaires about cognition, mood, sleep and function.
- Time commitment
- The study lasts about six months and includes the initial sleep test, follow‑up visits, and questionnaires during that period.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Evidence of cognitive impairment by any one of: (i) Montreal Cognitive Assessment (MoCA) score of 13-28, or (ii) Mini Mental State Examination (MMSE)...
- A diagnosis of: (i) Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to...
- Have the competency to provide informed consent, or the availability of a substitute decision maker/caregiver who can provide consent (if needed).
- The availability of a caregiver to assist in the completion of HSAT or iPSG, if needed.
You likely can't join if
- Prior diagnosis of OSA within the last 2 years
- Patients already using CPAP or a dental appliance for previously diagnosed OSA.
- A known contraindication for the use of the HSAT that will be used in this study: (a) Moderate to severe pulmonary disease or congestive heart...
- Any medical device that would interfere with the placement of the HSAT
- Significant physical impairment or language barrier that would restrict the ability to use the HSAT or complete the study assessments.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.