Sleep Disorders Trial, Recruiting NCT06993207 Sponsor: Bitbrain Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06993207
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

General requirements for all participants:

  • You are a native Spanish speaker.
  • You are willing to take part in tests and examinations as part of the study.
  • You are able to involve a close family member or friend to help with some assessments.
  • Your colour vision is normal, or you use glasses/lenses that correct it to normal.
  • You do not take any long-term medication that affects the mind or causes confusion.
  • You do not have a serious psychiatric or neurological condition (such as epilepsy with more than one seizure per month, or multiple sclerosis).
  • You do not have a serious illness that could affect memory or thinking (such as kidney failure requiring dialysis, liver cirrhosis, severe lung disease needing oxygen, an organ transplant, fibromyalgia, or active cancer being treated).
  • You do not have serious hearing or vision problems, or a developmental or movement disorder.
  • You have not had a significant brain injury, stroke, brain surgery, brain tumour, or brain chemotherapy or radiotherapy.
  • You have not taken antipsychotic medication in the 6 months before joining the study.
  • You do not take any psychiatric or neurological medication.
  • You do not have problems with alcohol or drug misuse.
  • You have not had any serious health problems (especially heart or neurological conditions) in the last 12 months.

If you have been diagnosed with mild dementia (Alzheimer's or vascular/mixed type):

  • You have a formal diagnosis of Alzheimer's-type dementia, confirmed by a doctor using clinical and cognitive assessments.
  • Or you have a formal diagnosis of vascular or mixed-type dementia, confirmed by a doctor.
  • You need some help with everyday tasks, both basic (such as dressing or bathing) and more complex activities (such as managing finances or using transport), as measured by standard assessment tools.

If you have been diagnosed with mild cognitive impairment (MCI):

  • You have a formal diagnosis of mild cognitive impairment, confirmed by a doctor using clinical and cognitive assessments.
  • You are still able to carry out everyday tasks independently, both basic and more complex activities, as measured by standard assessment tools.

If you have subjective cognitive decline (feeling your memory has worsened but no formal diagnosis):

  • You meet recognised criteria for subjective cognitive decline (confirm with trial site).
  • You have visited your GP with memory concerns that have lasted more than 6 months.
  • You have not been diagnosed with mild cognitive impairment or dementia.
  • Your memory concerns started within the last 5 years.
  • You or someone close to you has expressed concern about your memory (not triggered by a specific event).
  • Your scores on standard memory tests are within the normal range (confirm with trial site).
  • You do not have severe symptoms of depression, as measured by a standard questionnaire (confirm with trial site).

If you have no cognitive impairment (healthy control group):

  • Your scores on standard memory tests are within the normal range (confirm with trial site).
  • You have not been diagnosed with mild cognitive impairment or dementia.
  • You do not meet the criteria for subjective cognitive decline (confirm with trial site).
  • You live independently in your own home.
  • You have no concerns about your memory.

Who may not be able to join:

  • You are not a native Spanish speaker.
  • You have serious hearing, vision, developmental, or movement problems.
  • You have had a significant brain injury, stroke, brain surgery, or brain tumour.
  • You have a serious psychiatric or neurological condition (such as frequent epileptic seizures, multiple sclerosis, etc.).
  • You have a serious illness that could affect thinking (such as kidney failure on dialysis, liver cirrhosis, severe lung disease needing oxygen, active cancer under treatment, or fibromyalgia).
  • You have taken antipsychotic medication within the last 6 months.
  • You take any psychiatric or neurological medication regularly.
  • You have problems with alcohol or drug misuse.
  • You have had a serious health problem (especially heart or neurological) in the last 12 months.
  • You take long-term medication that affects the mind or causes confusion.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Bitbrain
Registry
ClinicalTrials.gov
Start date
15 January 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Validation of HoGar

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov